Articles tagged: Tysabri

Patients or loved ones of those who have been prescribed Tysabri and have developed Progressive Multifocal Leukoencephalopathy (PML) have the right to pursue a Tysabri Lawsuit in order to seek compensation for the injuries caused by Tysabri. The Willis law firm can help you file your Tysabri lawsuit.

A Tysabri lawsuit is filed to hold the makers of Tysabri, Biogen Idec and Élan responsible for the horrible and life changing injuries that may have been caused by their drug, Tysabri. Tysabri lawsuits claim that severe and detrimental health problems and or deaths occurred due to taking Tysabri as a treatment of multiple sclerosis (MS) or Crohn’s.

About Tysabri

Tysabri is a drug marketed by both Biogen Idec and Élan. Tysabri is primarily used to treat multiple sclerosis (MS) and Crohn’s disease. Administered by intravenous injection, Tysabri is injected approximately once every 28 days. Initially approved in 2004 by the FDA, Tysabri was subsequently withdrawn by the manufacturer after Tysabri was linked with multiple cases of progressive multifocal leukoencephalopathy (PML). Tysabri was reintroduced into the market in 2006, and cases of progressive multifocal leukoencephalopathy (PML) have been on the rise ever since.

Tysabri has been very effective at treating some patients for multiple sclerosis (MS), even causing a full remission of the disease, but patients taking Tysabri may be at risk of developing progressive multifocal leukoencephalopathy (PML) which can be more severe and life-threatening than MS. Currently, Tysabri’s packaging states that about 1.16 of every 1000 patients taking Tysabri will develop progressive multifocal leukoencephalopathy (PML). Approximately 80% of MS or Crohn’s patients taking Tysabri who are diagnosed with PML will die within six months of their PML diagnosis. Progressive multifocal leukoencephalopathy (PML) is the main topic of the Tysabri lawsuits.

At current time, there is no known cure for the development of progressive multifocal leukoencephalopathy (PML). It is a commonly found virus, approximately 80-90% of humans carry the virus in a latent form. It can flare and become dangerous when the immune system is down or through the use of drugs such as Tysabri. PML is more common among patients suffering from AIDS because of their weak immune systems. However, through aggressive immunotherapy treatment, approximately half of AIDS-PML patients may live. This number is higher than the survival rate of PML patients who took Tysabri.

Tysabri Lawsuit: Contact a Lawyer

If you or a loved one took Biogen Idec and Élan’s drug Tysabri to treat multiple sclerosis (MS) or Crohn’s disease and have developed progressive multifocal leukoencephalopathy (PML) please call and talk to a Tysabri lawyer today. Our lawyers are standing by, ready to investigate at no charge your potential Tysabri Lawsuit.

We encourage you to learn more about your legal options in pursuing a Tysabri Lawsuit against the makers of the dangerous drug. Contact the Willis Law Firm for a risk-free consultation about your potential Tysabri Lawsuit. You may be entitled to compensation for injuries sustained by Tysabri. All cases are handled on a Contingency Fee basis (no attorney fees or expenses charged unless we recover for you). Call us Toll Free at 1-800-883-9858

 

FDA Update on Tysabri PML

[04/22/2011]

FDA has updated the Tysabri (natalizumab) Prescribing Information to give new information about the size of the risk of progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection, associated with use of Tysabri for the treatment of multiple sclerosis (MS) and Crohn’s disease. The update includes new safety information about patients who have taken other drugs that suppress the immune system, who may be at a higher risk for PML. Tysabri, in a class of medications called immunomodulators, has been approved by the FDA for the treatment of relapsing forms of multiple sclerosis since November 2004 and for the treatment of moderately to severely active Crohn’s disease since January 2008. The revised label includes a table summarizing rates of PML with Tysabri use according to the number of infusions (how long the drug is taken or duration of exposure) and information on a newly identified PML risk factor.

[02/05/2010]

FDA notified healthcare professionals and patients that the risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received. This new safety information, based on reports of 31 confirmed cases of PML received by the FDA as of January 21, 2010, will now be included in the Tysabri drug label and patient Medication Guide. Information about the occurrence of immune reconstitution inflammatory syndrome (IRIS) in patients who have developed PML and subsequently discontinued Tysabri has also been added to the drug label. IRIS is a rare condition characterized by a severe inflammatory response that can occur during or following immune system recovery, causing an unexpected decline in a patient’s condition after return of immune function.

Based on the available information, FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks. Revisions to the drug label and patient Medication Guide, with the continued use of the TOUCH Prescribing Program, are intended to maximize the safe use of Tysabri and the identification of new PML cases.

FOR IMMEDIATE RELEASE:

Tysabri PML Lawsuits – Willis Law Firm Representing Families of Two Tysabri PML Patients

Houston, Texas – December 20, 2010 – The Willis Law Firm, currently representing two of the fewer than seventy-five known cases of Tysabri induced PML worldwide, is accepting new Tysabri PML clients and lawsuits.

According to the FDA, Tysabri (also known as natalizumab), a drug prescribed in the treatment of Multiple Sclerosis (MS) and Crohn’s disease, has been linked to the increased risk of progressive multifocal leukoencephalopathy (PML).  PML is a very rare and opportunistic viral infection of the brain that usually leads to severe disability and/or death. Tysabri was pulled from the market over safety concerns in 2005 but returned a year later in 2006.

Current Willis Law Firm Tysabri PML clients include:

  • 36 year old female multiple sclerosis patient who had been infused with Tysabri 24 times over a period of two years.  She was diagnosed with PML in 2009 and is now under 24 hour care and has lost the ability to communicate.  She was a member of the Tysabri “Touch Program” and is listed as only the 7th Tysabri PML case in the world and only the 2nd in the U.S. 
  • Family of a deceased 40 year old multiple sclerosis patient and mother of two.  According to medical records, the patient’s MS symptoms were under control at the time she was prescribed Tysabri.  Following only her second Tysabri infusion, she experienced a sudden onset of PML-like symptoms, suffered a rapid decline in health, and eventually died within 30 days of the Tysabri infusion.  Our firm’s medical consultants believe this is suggestive of a possible Tysabri PML link.

In a letter dated March 25, 2010, the US FDA notified the Senior Vice President of Regulatory Affairs for Biogen Idec, Inc., the manufacturer of Tysabri, that Biogen’s promotion of Tysabri contained “false or misleading” information. The letter went on to state that Biogen’s promotional information regarding Tysabri “minimizes important risks associated with the use of Tysabri and omits the drug’s approved indication.”

Biogen has ceased sharing information with the public on their corporate website regarding any new PML cases.  This was announced after the 11th documented PML patient, back in March of 2009.  Biogen currently states that “any new cases will be reported by word of mouth to medical professional and patient groups”.

Patients and/or family members of those treated with Tysabri infusions and then later diagnosed with PML are encouraged to contact The Willis Law Firm to speak to a Tysabri PML lawyer about their legal options regarding the possible filing of a Tysabri PML Lawsuit.  Please keep in mind that certain states have statutes of limitation which limit the amount of time a person may have to file a lawsuit or seek legal action. All cases are taken on a Contingency Fee Basis. No fees or expenses are charged to the client unless a recovery is made, or settlement obtained for the Tysabri PML patients and their families.

“The expertise that our firm has gained in the assistance of our current group of Tysabri PML clients and their families has given us the unique perspective required to help these victims and pursue this rare and complex type of case”, stated  David P. Willis, principal attorney at The Willis Law Firm.

The Willis Law Firm, a Nationally Recognized Drug Litigation Law Firm, is dedicated to fighting for the rights of those harmed by dangerous and recalled drugs and medical devices.  For 25+ years, Attorney David P. Willis, a Board Certified Personal Injury Trial Lawyer, has represented seriously injured clients and their families in product liability, personal injury, and defective drug litigation lawsuits involving pharmaceutical and medical device companies. Mr. Willis is licensed in Texas and New York and assists victims of defective products and dangerous drugs nationwide. For more information, call The Willis Law Firm toll free at: 1-800-883-9858 or visit www.Tysabri-PML.com

Contact:

David P. Willis
press@injuryoffices.com
1221 McKinney Street
Suite 3333
Houston, Texas 77010
USA

Ph: 800-883-9858
www.drug-attorneys.com

###

PML is a rare disorder that damages the material that covers and protects the nerves in the white matter of the brain. It is caused by the reactivation of the JC virus in the body and it infects the brain. JC virus is commonly acquired in childhood, but most people do not develop PML. The virus usually remains inactive and hardly ever causes symptoms-unless you have a significantly weakened immune system. People who have received Tysabri infusions, have AIDS, leukemia or lymphoma typically have a compromised immune system.

PML and Tysabri

Tysabri (Natalizumab) is a drug manufactured by Biogen Idec Inc. and Elan Corp. It is used to treat the symptoms of Multiple Sclerosis (MS) and Crohn’s disease, a gastrointestinal disorder. It is normally used after other treatments have not worked; it is not a cure, but a treatment. Tysabri is an immunosuppressant infusion that is used to help control the symptoms of relapsing MS (when the symptoms get worse then improve, and get worse again.) The use of Tysabri has been linked to PML (Progressive multifocal leukoencephalopathy), a rare but life threatening brain infection. The longer Tysabri is used, the more likely the risk of contracting PML.

Symptoms of PML

There is no “usual” course of PML, the area of the brain that is affected will determine how PML symptoms will appear. The symptoms can be similar to those of MS, and worsen rapidly. Some of the symptoms may include the following:

  • Headaches
  • Loss of balance and coordination
  • Slurred speech, or loss of speech (aphasia)
  • Memory Loss, confusion, disoriented
  • Vision Problems that cause blurred vision or loss of vision
  • Weakness or paralysis of one side of the body
  • Tiredness
  • Seizures

PML Diagnosis

The most accurate way to diagnose PML is by a brain biopsy. But, most brain specialists can diagnose PML by the patient’s clinical symptoms along with a MRI scan, and testing the Cerebrospinal fluid (CSF) for the JC virus. If PML is suspected the Tysabri should be stopped immediately and a clinical evaluation should be performed.

PML Treatment

There is no known cure for PML that is caused by Tysabri. In some cases, the disease may slow or stop once the medication is discontinued, but only if the patient’s immune system improves. The experimental drug treatments used for PML caused by Tysabri have not been very effective. PML is usually fatal and those who do survive the disease are often permanently disabled. Tysabri is intended to help those who suffer from MS or Crohn’s disease that other treatments have been unable to help, but in fact it may actually be fatal instead.

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Every attorney at our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit with an Attorney.

Tysabri PML Lawsuits

TysabriTysabri is a drug prescribed to help patients with multiple sclerosis or Crohn’s disease. Recent reports to the FDA has shown that Tysabri infusions increase the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Cases of PML have been reported to the FDA in patients taking Tysabri who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving Tysabri as monotherapy.

Tysabri Side Effects

Tysabri PML is a rare and often fatal infection of the brain. The risk of developing PML increases with the number of Tysabri infusions a patient has received. There is no known cure for progressive multifocal leukoencephalopathy (PML).

Tysabri FDA Warning

The FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri. Tysabri was approved by the FDA for the treatment of relapsing forms of multiple sclerosis (MS) in November 2004 and for moderately to severely active Crohn’s disease in January 2008.

Tysabri and PML Information

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Every attorney at our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit with an Attorney.

 

    DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service  

Food and Drug Administration Silver Spring, MD 20993

 

TRANSMITTED BY FACSIMILE

March 25, 2010

Nadine D. Cohen Senior Vice President, Regulatory Affairs Biogen Idec, Inc. 14 Cambridge Center Cambridge, MA 02142

RE: BLA #125104

TYSABRI® (natalizumab) injection for intravenous use MACMIS # 18025

Dear Ms. Cohen:

As part of its monitoring and surveillance program, the Division of Drug Marketing, Advertising, and Communications (DDMAC) of the U.S. Food and Drug Administration (FDA) has become aware of a promotional webcast conducted by Biogen Idec, Inc. (Bigoen) for TYSABRI® (natalizumab) injection for intravenous use (Tysabri). The webcast was conducted twice on each of the following dates for a total of eight webcasts: October 28, October 30, November 2 and November 4, 2009. The webcast is false or misleading because it minimizes important risks associated with the use of Tysabri and omits the drug’s approved indication. The webcast thus misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(a) & (n); 321(n). See 21 CFR 202.1(e)(3)(ii); (e)(5)(i) & (iii); (e)(6)(i). Furthermore, the webcast was not submitted to FDA thirty days prior to the intended time of initial dissemination or initial publication, as required by 21 CFR 601.45. Moreover, Biogen failed to submit the webcast to FDA under cover of Form FDA-2253 at the time of initial publication, as required by 21 CFR 601.12(f)(4). Cf. 21 CFR 314.81(b)(3)(i).

Background

According to its FDA-approved product labeling (PI), Tysabri’s indication is as follows (in pertinent part):

TYSABRI is indicated as monotherapy for the treatment of patients with relapsing forms of multiple sclerosis to delay the accumulation of physical disability and reduce the frequency of clinical exacerbations. The safety and efficacy of TYSABRI beyond two years are unknown.

Because TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability, TYSABRI is generally recommended for patients who have had an inadequate response to, or are unable to tolerate, an alternate multiple sclerosis therapy.

Safety and efficacy in patients with chronic progressive multiple sclerosis have

not been studied.

Tysabri is associated with numerous risks. The PI contains the following boxed warning for PML (in pertinent part) (bolded emphasis in original; underlined emphasis added):

TYSABRI increases the risk of progressive multifocal leukoencephalopathy (PML), an opportunistic viral infection of the brain that usually leads to death or severe disability. Cases of PML have been reported in patients taking TYSABRI who were recently or concomitantly treated with immunomodulators or immunosuppressants, as well as in patients receiving TYSABRI as monotherapy. . . .

  • Because of the risk of PML, TYSABRI is available only through a special restricted distribution program called the TOUCH™ Prescribing Program. . . .
  • Healthcare professionals should monitor patients on TYSABRI for any new sign or symptom that may be suggestive of PML. TYSABRI dosing should be withheld immediately at the first sign or symptom suggestive of PML. . . .

The PI also contains Warnings and Precautions for PML as follows (in pertinent part, emphasis added):

The absolute risk for PML in patients treated with TYSABRI cannot be precisely estimated, and factors that might increase an individual patient’s risk for PML have not been identified. There are no known interventions that can reliably prevent PML or adequately treat PML if it occurs. It is not known whether early detection of PML and discontinuation of TYSABRI will mitigate the disease. There is limited experience beyond two years of treatment. The relationship between the risk of PML and the duration of treatment is unknown, but most cases of PML were in patients who received more than one year of treatment . . . .

The incidence of PML appears to be lower in patients receiving TYSABRI as monotherapy; however, the number of cases is too few and the number of patients treated too small to reliably conclude that the true risk of PML is lower in patients treated with TYSABRI alone than in patients who are receiving other drugs that decrease immune function or who are otherwise immunocompromised .

The progression of deficits usually leads to death or severe disability over

weeks or months .

There are no known interventions that can adequately treat PML if it occurs.

There is no evidence that plasma exchange has any benefit in the treatment of opportunistic infections such as PML. Because of the increased risk of PML in patients, Tysabri was withdrawn from the market in February 2005. In July 2006, Tysabri was reintroduced to the market with a boxed warning for PML and the TOUCH restricted distribution program.

Tysabri is contraindicated in patients who have or have had PML, and who have had a hypersensitivity reaction to Tysabri. Tysabri also has Warnings and Precautions pertaining to a restricted distribution program for Tysabri (TOUCH™ Prescribing Program), hypersensitivity/antibody formation, immunosuppression/infections, hepatotoxicity, laboratory test abnormalities, and immunizations. The most frequently reported serious adverse reactions in the Tysabri monotherapy trial relative to placebo were infections (3.2% vs 2.6%, including urinary tract infection (0.8% vs 0.3%) and pneumonia (0.6% vs 0%)), acute hypersensitivity reactions (1.1% vs 0.3%, including anaphylaxis/anaphylactoid reaction (0.8% vs 0%)), depression (1.0% vs 1.0%, including suicidal ideation or attempt (0.6% vs 0.3%)), and cholelithiasis (1.0% vs 0.3%). The most common adverse events reported at an incidence of >10% and relative to placebo were headache (38% vs 33%), fatigue (27% vs 21%), infusion reactions (24% vs 18%), urinary tract infections (21% vs 17%), arthralgia (19% vs 14%), depression (19% vs 16%), lower respiratory tract infection (17% vs 16%), pain in extremity (16% vs 14%), rash (12% vs 9%), gastroenteritis (11% vs 9%), abdominal discomfort (11% vs 10%), vaginitis (10% vs 6%), and diarrhea NOS (10% vs 9%).

Minimization of Important Risk Information

The webcast focuses on the risk of PML that is associated with Tysabri. We are particularly concerned with this webcast because it presents numerous statements that seriously minimize the risk of PML. For example, the webcast presents the following claims (emphasis added):

  • “Heightened clinical vigilance led to prompt natalizumab discontinuation upon first signs or symptoms suggestive of PML
  • The majority of patients who developed PML in the post-marketing setting received plasma exchange . . . to accelerate removal of natalizumab
  • Majority of natalizumab-treated patients who developed PML have survived and exhibit varying levels of disability

This presentation misleadingly implies that Tysabri patients who developed PML and received treatment (e.g., plasma exchange) experienced lessened effects of PML and that patient outcomes will necessarily be improved if Tysabri treatment is stopped at the first sign of PML; this has not been established. According to the Warnings and Precautions section of the PI, “. . . [t]here are no known interventions that can reliably prevent PML or adequately treat PML if it occurs. It is not known whether early detection of PML and discontinuation of TYSABRI will mitigate the disease. . . . There is no evidence that plasma exchange has any benefit in the treatment of opportunistic infections such as PML” (emphasis added). It is misleading to suggest that early detection of PML and prompt discontinuation of Tysabri will lessen any effects of PML.

This presentation also misleadingly implies that a significant portion of Tysabri-treated patients who develop PML survive and may only experience non-severe disabilities; this has not been established. Tysabri’s boxed warning (and Warnings and Precautions section) clearly states that PML is “. . . an opportunistic viral infection of the brain that usually leads to death or severe disability” (bolded emphasis in original; underlined emphasis added). In addition, as of the date of the first webcast, four of the first fourteen cases of PML reported since the reintroduction of Tysabri into the market in April 2006 had resulted in death, at least an additional three patients appeared moribund, and there was insufficient data on the remaining PML cases to make an assessment of outcome to support the implication conveyed by the last claim above (i.e., that Tysabri patients who develop PML are likely to survive and may only experience minor disabilities). This presentation fails to provide any further information on the actual functional status of patients affected by PML (e.g., by a Rankin scale). Overall, this presentation misleadingly minimizes the severity of the risk of PML associated with Tysabri.

In addition, the webcast presents the following claims pertaining to the incidence of the risk of PML:

  • “The incidence of PML increases with treatment duration − No cases in MS during the first year of treatment − Incidence in patients treated for < 2 years appears to be <1 per 1000 − Incidence in patients treated for 2-3 years appears to be about 1 per 1000 − Not enough evidence patients treated for > 3 years to be confident of incidence”
  • “The incidence of PML in the post-marketing setting is within the 1 in 1000 incidence implied in the label”

These claims misleadingly suggest that the risk of PML can be predicted based on an established treatment time range, when this is not the case. Specifically, the claims above suggest that PML risk can be definitively categorized into timeframes (i.e., 0-1 year, < 2 years, 2-3 years, and > 3 years); however, there is no evidence to support such a categorization of risk assessment. The risk of PML increases steadily over time. It is misleading to suggest that the PML risk associated with Tysabri use can be determined based an arbitrary cutoff of treatment duration.

Omission of Indication

Although the webcast discusses the use of Tysabri in “MS patients,” it fails to communicate any information about Tysabri’s approved indication for multiple sclerosis.

Failure to Submit

FDA regulations require the sponsors of biological products approved through the accelerated approval process, such as Tysabri, to submit promotional materials including promotional labeling and advertisements at least thirty days prior to the intended time of initial dissemination of the labeling or initial publication of the advertisement. A copy of the webcast was not submitted to FDA 30 days prior to the intended time of initial dissemination or publication, as required by 21 CFR 601.45.

FDA regulations also require sponsors to submit specimens of mailing pieces and any other labeling or advertising devised for promotion of biological products at the time of initial dissemination of the labeling and at the time of initial publication of the advertisement for a biological product. Each submission is required to be accompanied by a completed transmittal Form FDA-2253 (Transmittal of Advertisements and Promotional Labeling for Drugs for Human Use) and is required to include a copy of the product’s current professional labeling. A copy of the webcast was not submitted to FDA under cover of Form FDA-2253 as required by 21 CFR 601.12(f)(4). Cf. 21 CFR 314.81(b)(3)(i). We acknowledge an October 28, 2009, email to the Division of Neurology Products (DNP) which states your intent to hold “several webcasts regarding Tysabri and PML,” along with a copy of the invitation, which was sent to all prescribers enrolled in the TOUCH program, to attend this webcast. However, this does not satisfy the requirements described above.

Conclusion and Requested Action

For the reasons discussed above, the webcast misbrands Tysabri in violation of the Act, 21

U.S.C. 352(a) & (n); 321(n). See 21 CFR 202.1(e)(3)(ii); (e)(5)(i) & (iii); (e)(6)(i). Furthermore, the webcast was not submitted to FDA thirty days prior to the intended time of initial dissemination or initial publication, as required by 21 CFR 601.45. Moreover, Biogen failed to submit the webcast to FDA under cover of Form FDA-2253 at the time of initial publication, as required by 21 CFR 601.12(f)(4). Cf. 21 CFR 314.81(b)(3)(i).

DDMAC requests that Biogen immediately cease the dissemination of violative promotional materials for Tysabri such as those described above. Please submit a written response to this letter on or before April 9, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Tysabri that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Please direct your response to the undersigned at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD, facsimile at

(301) 847-8444. In all future correspondence regarding this matter, please refer to MACMIS #18025 in addition to the BLA number. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Tysabri comply with each applicable requirement of the Act and FDA implementing regulations.

Sincerely,

/S/

Amy Toscano, Pharm.D., CPA

Regulatory Review Officer

Division of Drug Marketing,

Advertising, and Communications

Tysabri Label Update

New safety information will be included in the Tysabri (natalizumab) drug label and patient Medication Guide: The risk of developing progressive multifocal leukoencephalopathy (PML) increases with the number of Tysabri infusions received.

PML is a rare brain infection that usually causes death or severe disability. This new safety information is based on reports of 31 confirmed cases of PML received by FDA as of Jan. 21, 2010.

The drug label will also include information about the occurrence of immune reconstitution inflammatory syndrome (IRIS) in people who developed PML and then stopped using Tysabri. IRIS is a rare but severe inflammatory response that can cause worsening of multiple sclerosis.

Tysabri is approved to treat relapsing forms of multiple sclerosis, and moderately to severely active Crohn’s disease. (PMS has not been reported in people treated with Tysabri for Crohn’s disease.)

At this time, FDA believes that the benefits of Tysabri continue to outweigh the potential risks.

Recommendation: If you take Tysabri, call your health care professional right away if you get any new or worsening medical problems (such as a new or sudden change in your thinking, eyesight, balance, or strength or other problems) that have lasted over several days.

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Every attorney at our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit with an Attorney.

(Reuters) - Lisa Richwine – WASHINGTON - Fri Feb 5, 2010 1:34pm EST

The risk of a potentially fatal brain disorder (PML) with Biogen Idec Inc’s multiple sclerosis drug Tysabri increases as patients receive more infusions, U.S. health officials warned on Friday.

The prescribing instructions for Tysabri will be updated to warn of the higher risk with more treatment, the Food and Drug Administration said. Elan Corp co-markets the drug.

The FDA said the warning was based on 31 confirmed cases of progressive multifocal leukoencephalopathy (PML), a brain infection that can be fatal. Eight patients have died.

“Based on the available information, the FDA believes that the clinical benefits of Tysabri continue to outweigh the potential risks,” the FDA said in a notice on its website.

Tysabri was temporarily withdrawn from the market in 2005 because of its link to PML.

Biogen spokeswoman Naomi Aoki said “there was nothing I thought was new” in the FDA notice.

“Either it was included as part of our last label update or it was information that we are making available on a monthly basis,” she said.

Biogen updates the number of PML cases each month to doctors on request but no longer posts the figure on its website or issues a press release.

Elan officials were not immediately available for comment.

Tysabri is given as a single infusion every four weeks. About 66,000 people worldwide have been treated with the drug since it reappeared on the market in 2006, the FDA said.

The PML rate for patients given at least one infusion is 0.5 cases per 1,000 patients, the FDA said. For patients given at least 24 infusions, the PML rate is 1.3 per 1,000.

The FDA move comes two weeks after a similar announcement by European regulators, who also said Tysabri’s benefits outweighed risks.

The drug carries a boxed warning, the strongest type for prescription drugs, about the PML risk. All patients must enroll in a monitoring program for PML or other serious infections called: “The Touch Program”. The drug’s generic name is natalizumab.

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit.

Tysabri’s PML Count Climbs, and Some Reflections From Biogen Idec’s Departing CEO

Luke Timmerman 1/6/10

At least one more patient has been diagnosed with a rare, and potentially fatal brain infection after taking natalizumab (Tysabri), the hit drug for multiple sclerosis from Biogen Idec and Elan, according to Biogen CEO James Mullen.

There are now 28 confirmed cases of patients with progressive multifocal leukoencephalopathy (PML) as of the last count in mid-December. That’s one more case than I counted in a detailed summary of PML risk that we published on November 19. Mullen made his remarks in front of a group of investors today at a Goldman Sachs conference titled “Healthcare CEOs Unscripted: A View From the Top.”

Mullen talked about the hit drug’s difficult history with PML as part of a wide-ranging and candid conversation with Goldman analyst May-Kin Ho in New York. These were the first public remarks Mullen, 51, has made since the Cambridge, MA-based company (NASDAQ: BIIB) announced this week he is stepping down in June as CEO, after a decade at the helm. He offered his thoughts on how to mitigate the risk for multiple sclerosis patients, his reflections on what worked and what didn’t in the 2003 merger with San Diego-based Idec Pharmaceuticals, and how the industry needs to change its ways to keep innovation alive. Here are the highlights that I picked up from the webcast.

On how Biogen Idec plans to keep doctors, patients, and investors informed about PML risk:

Biogen Idec says it plans to offer monthly updates to physicians about the latest statistics on PML cases, and infection rates. It will also staff a hotline for physicians who want to gather detailed, updated information and context from the company’s medical staff. The company plans to lay out the numbers in a more detailed fashion, with rates on incidence of infection, numbers showing how long certain groups of patients have been on the drug, combined with data on how many total patients are receiving treatment. “That’s the best way for people to visualize what’s going on,” Mullen says.

“The whole communications strategy around that has been challenging,” Mullen said. “We’ve gotten lots of feedback. Pretty much whatever we’ve done, someone won’t like it.”

On why he’s leaving the company in June:

Mullen noted that the Tysabri risk-management situation has stabilized during the past year. A new patent that lasts until 2026 has extended the lifespan of pegylated interferon beta (Avonex) which may help it fend off cheaper “follow-on” biologic competitors. And the product pipeline looks encouraging as well, he said.

“There are a lot of good prospects out there for Tysabri, and there aren’t, if you will, a lot of huge, thorny issues to be wrestled to the ground here in the short term. It’s a good time for a transition.”

From a personal perspective, he added: “If you’re going to have a mid-life crisis, you can do one of two or three things, right? Sports cars I’m too big for. Mistresses are not approved at home. Maybe a career change is what’s in order. I decided to go with Number 3. I think it’s a good time, for, you know, a transition. We’ve also got a new chairman with Bill Young. We’ve got some new board members. We’ll have a few more new board members. It’s a good time for people to sort of re-think about the strategy and get some fresh views.”

On his plans after June:

“A lot of people don’t think I take advice very well, but one of the pieces of advice I got from a lot of people was—finish what you’re doing, clear your head, take some time, and consider the different options on what you plan to do. That’s what I intend to do.”

On the status of competing MS drugs:

“Anybody else’s delay is our good news.” Given the well-known PML risk with natalizumab, Merck KGaA’s cladribine, and Novartis’ FTY-720, those companies will have to deal with more regulatory scrutiny, Mullen said. “The safety scrutiny has gone up and up and up. In the U.S., everyone is going to have to have a REMS [risk evaluation and mitigation strategy]. It might be modest, or it might be as restrictive or tight as Tysabri’s.”

“Certainly an oral product will [find] a lot of interest in the marketplace. On the other hand, that product also has some fairly significant safety issues and it’s going to have a REMS program. I think the established safety and efficacy profile of the ABCRs [Avonex, Betaseron, Copaxone, & Rebif, the standard treatments] is such that they are the first-line therapies, and it will be true for some period of time.”

On how to mitigate the risk of PML by testing for biomarkers to gauge a patient’s vulnerability:

“We have done, since 2005, a tremendous amount of work to look at anything and everything to mitigate the risk around this product. Certainly the JCV antibody test, we think, is the most solid diagnostic we have seen. The data as we developed it have tipped over some of the widely held beliefs that essentially everybody here was going to be JCV antibody positive, because we’ve all been exposed to JC virus [the virus that crosses into the brain and causes PML]. It looks like it’s more like half of us. We also have serum samples from patients with PML, and they were all JCV positive. So it’s a solid assay.

“But then there’s chatter about what does it mean for JCV antibody positive patients? You really have to put yourself in the shoes of those patients. Right now, Tysabri is a third or fourth line product. The 48,000 patients who are on it have failed one or more therapies. They aren’t doing well. Their options are being exhausted rapidly. When they look at being JCV antibody positive or negative, the question is, ‘How am I doing on the product?’ If I’m doing well on the product, they’ll be left on the product, and probably monitoring will increase. The more we can learn about other risk factors will be helpful. For those who are negative, it opens up the question of whether we should treat patients who are negative, at least some of them, more aggressively, and earlier. So that’s a potential opening to go there. Everything else we learn over time to further parse the risk is all to their benefit.”

On what worked, and what didn’t, in Biogen’s 2003 merger with San Diego-based Idec Pharmaceuticals:

“Now you’re really taking us back to ancient history. Here’s what went as expected. The combination of the two companies really allowed us to fundamentally re-allocate capital in a different way than either one was doing. They had a lot of the oncology infrastructure. We had the international footprint. We brought better manufacturing capabilities. They brought much better process sciences. Developing the processes to go into manufacturing. That has had a terrific payoff. Those two things came together seamlessly. It allowed us to compete much better, and more broadly, on business development. We’ve done a lot of small and mid-sized deals. Half of the pipeline today comes out of business development.

“In terms of things that exceeded expectations from the original models we had? Rituxan is much bigger. By being in RA [rheumatoid arthritis, as well as non-Hodgkin's lymphoma], the whole CD20 area turns out to be more important. As does the durability and size of the Avonex business and the MS franchise, which turned out to be better.

“But some of the products that were in the pipeline at that point that we thought would be important products, frankly, they haven’t. Amevive basically got wiped out by the anti-TNFs [what's that]. Raptiva is gone from the market, it has a little problem with that three-letter word we don’t like to say—PML. That’s gone from the market, Amevive is still on the market, but disappointing. Zevalin never really lived up to what we hoped would be its commercial potential. And some of the late-stage pipeline candidates evaporated, as tends to happen in this business.

“From an integration of people standpoint, it always takes a little longer, but right now, it works pretty well. The R&D being bi-coastal works very seamlessly and smoothly. Most oncology is done on the West Coast, most of the immunology is done on the East Coast, but some is on the West Coast, and pretty much all of the neurology is on the East Coast. Then there’s a lot of shared infrastructure, and that works pretty well.”

On the biggest surprises of his 20-year career in biotechnology:

“What surprises me is that it’s very hard to pick out which technologies and products will turn into the blockbusters. I remember the conversations going in the early ’90s, happening in our place, when people said, ‘This monoclonal antibody stuff, it’s not going to turn into any products.’ It’s not quite right. And we are one of the biggest beneficiaries of that. Gene therapy was going to be huge. Then it was RNAi. And all sorts of other stuff.

“It’s always been difficult to pick the technologies and platforms that will turn into products because it always sounds a lot easier than it is and more logical than the biology turns out to be. That’s one. The second is that regulatory success by no means [translates into commercial success]. You really have to think carefully about all your products. Just getting over the regulatory hurdle, and getting the whole organization to understand that getting over the regulatory hurdle is not sufficient.

“How intractable the whole R&D productivity issue has been for the industry. I’ve been around 30 years in the industry, and every three or four years along comes some new thing that’s going to somehow improve our hit rate or drop the costs. Well, none of that has happened. The regulatory hurdles go up, the trial sizes go up, the timelines get longer, things get more expensive, and the hit rates don’t go up, they go down.

“If I want to be futuristic, I would ask how we’re going to change the paradigm. We’re still living in a paradigm of placebo-controlled trials that were put in place in the 60s, 70s and 80s. It won’t work any longer over the next 30 or 40 years. Frankly, a lot of basic problems got solved. This idea that you’re going to do comparative effectiveness studies—they sound great as headlines, and they play well with the public, but when you run the statistics, they don’t work at all.

“So I think there’s got to be really new thinking in the industry. It’s going to take a while, and it will need to take hold with the regulators. The whole Critical Path Initiative at the FDA has always been disappointingly underfunded, and do not [have] enough intellectual horsepower, but the industry has to rally around it and help come up with some new paradigms, and move the regulators to a point where the paradigms are meaningful and put into place. This whole equation is heading to a place where innovation is really going to be crimped.”

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Every attorney at our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit with an Attorney.

11th Tysabri Patient Develops PML

Tysabri patient develops PML and will be the last to be reported on the Biogen website.

An 11th patient taking Biogen Idec’s multiple sclerosis (MS) drug Tysabri has developed a potentially deadly brain infection.

In the latest confirmed case of progressive multifocal leukoencephalopathy, or PML, the patient took Tysabri for 29 doses, continuing the trend of the last six reported cases of the infection, where each patient had therapy for two years or longer.

The latest patient was located in the USA, the third American to have developed the infection. Of the 11 reported cases, one patient has died.

The PML incidence rate remains below the long-projected risk rate of one in 1,000 patients for those patients receiving the therapy for 12 months or 18 months.

The drug was temporarily withdrawn in 2005 after it was linked with PML, but was then brought back in 2006 with stricter safety warnings.

Tysabri continues to receive strong support from patients and doctors, however, because of the drug’s perceived effectiveness. That support has remained steady because patients are made well-aware of the PML risk before they start taking Tysabri for MS.

This is the last case of PML that the company plans to announce on its website. In future any new cases will be reported by word of mouth to medical professional and patient groups.

Tysabri PML Lawyer

If you or a family member has been diagnosed with PML, or been treated with Tysabri infusions, contact our law firm to speak to a PML lawyer about your legal options. Every attorney at our law firm is dedicated to fighting for the rights of those that have been harmed by dangerous and recalled drugs and medical devices. For over 25 years, Attorney David Willis has been a trial lawyer representing seriously injured clients in product liability and personal injury lawsuits such as defective drug litigation, class action drug lawsuits and medical device recall lawsuits. If Tysabri has harmed you, or a loved one, contact us right now to discuss your potential case in filing a Tysabri PML Lawsuit with an Attorney.