Posted on 03/02/2005 5:10:48 PM PST by Magnolia
Tysabri Suspended From The Market
February 28, 2005
Biogen Idec and Elan Corporation have just announced the voluntary suspension of Tysabri from the market and from all clinical trials due to safety concerns. Tysabri was approved for marketing in November 2004.
According to the company press release, "This decision is based on very recent reports of two serious adverse events that have occurred in patients treated with TYSABRI in combination with AVONEX® (Interferon beta-1a) in clinical trials. These events involve one fatal, confirmed case and one suspected case of progressive multifocal leukoencephalopathy (PML), a rare and frequently fatal, demyelinating disease of the central nervous system. Both patients received more than two years of TYSABRI therapy in combination with AVONEX." The companies are investigating these events further.
The National Multiple Sclerosis Society was distressed to learn of the unfortunate adverse events that have occurred in two patients treated with Tysabri in combination with Avonex in clinical trials. Our deepest sympathies go out to both families.
We commend the quick action Biogen Idec and Elan Corporation have taken in voluntarily suspending use of Tysabri while they investigate the possible link between Tysabri and PML.
It will be disappointing if the investigation suggests that Tysabri cannot be safely returned to the market as a therapy for multiple sclerosis. There are five other approved disease-modifying therapies available for the treatment of MS.
See below for Questions and Answers about this situation.
The FDA issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri and will maintain close contact with the company as it investigates these serious adverse events further.
For more information from the FDA, including the public health advisory and questions and answers on the Tysabri suspension, go to:
www.fda.gov/cder/drug/infopage/natalizumab
To access the companies’ letter to healthcare professionals, download:
www.tysabri.com/hcp.pdf
Questions & Answers About the Marketing Suspension of Tysabri
Q: What were the adverse events related to the suspension of Tysabri?
A: Two individuals who were taking Tysabri and Avonex (interferon beta-1a) in combination experienced adverse events that led to the suspension of Tysabri. One adverse event was confirmed as a fatal case of PML and the other as a possible case of PML which is still under investigation.
The adverse events occurred after these individuals had completed participation in the SENTINEL trial (where people on Avonex began taking Tysabri as an add-on treatment), but were continuing therapy as part of an extension study. They had been taking the combination therapy for over two years.
Q: What is PML, and is it treatable?
A: According to the National Institutes of Health, progressive multifocal leukoencephalopathy is a rare, rapidly progressive disorder of the nervous system that is caused by a common virus, the “JC virus.” It usually occurs in persons who have severe immune-system suppression. Symptoms include mental deterioration, vision loss, speech disturbances, loss of coordination, paralysis, and ultimately coma and usually death. There is no cure for PML, and no effective treatment, except to treat some of its symptoms.
Q: Is the company reviewing all patients who have taken Tysabri for possible PML?
A: The companies have stated that they are evaluating the patients who received treatment during the clinical trials of Tysabri. They are also attempting to inform all patients in their database about the situation.
Q: What can we tell clients who have taken Tysabri and have concerns about their own safety?
A: In a Public Health Advisory issued February 28, 2005 (www.fda.gov/cder/drug/advisory/natalizumab.htm) the U.S. Food and Drug Administration suggests that patients being treated with Tysabri contact their physician to discuss appropriate alternative treatments. “At this time, there are no specific diagnostic or therapeutic interventions recommended for patients who have been taking Tysabri, other than to discontinue its use.”
Q: Are people who were on Tysabri in danger of something happening even after they stop taking it?
A: At this time, no one knows. Individuals should discuss their concerns with their personal physicians. The FDA recommends that physicians should evaluate all patients who have received Tysabri for any signs or symptoms suggestive of PML.
Q: Does this suspension mean that Tysabri will never be available to treat MS?
A: Not necessarily. The fate of Tysabri for MS will depend on the investigation of the adverse events that occurred, and a thorough evaluation of the data available from all treated patients involved in the clinical trials of Tysabri. It is possible that Tysabri will be removed permanently from the market, and it is also possible that Tysabri will be returned to the market.
Q: How long will the company’s investigation of Tysabri take?
A: No one currently knows, but the company is working as quickly as possible and has put together a panel of experts on PML to assist in the investigation.
Q: Is the suspension of Tysabri a setback to the search for a cure?
A: This is certainly a disappointment, but there are many other approaches being taken to treat MS. In the meantime, scientists continue their work to find a cure for this disease.
Q: What should physicians do who have been treating their patients with Tysabri?
A: The FDA recommends that physicians should evaluate all patients who have received Tysabri for any signs or symptoms suggestive of PML. Any suspected cases of PML should be reported to Biogen Idec or the FDA MedWatch Program (1-800-FDA-1088).
Oops...just noticed my typo in the heading. The correct date is 2-28-05 NOT 95!
MS bump!
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