Neuroscience
From the FDA:
FOR IMMEDIATE RELEASE
P06-25
February 16, 2006
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed
The Food and Drug Administration (FDA) is reporting that Biogen-IDEC and Elan Corporation announced yesterday that FDA removed the clinical hold on Biogen-IDEC's studies of Tysabri (natalizumab) for patients with multiple sclerosis. This will allow clinical trials to go forward. In February 2005 Biogen-IDEC had announced suspension of marketing and clinical trials after three patients developed progressive multifocal leukoencephalopathy (PML), a frequently fatal infection of the brain, two following treatment with natalizumab for MS, and one patient being treated for Crohn's Disease. Two of these cases were fatal.
The removal of the clinical hold allows patients with MS who were previously treated with the drug under an investigational (IND) study to resume treatment in an IND study following discussion with their physicians about the potential risks and potential benefits of treatment. Although this treatment has been shown to have benefit in patients with relapsing-remitting MS, concern about the risk of PML associated with use of Tysabri remains.
FDA has worked with Biogen-IDEC over the ensuing months to assess whether any other patients exposed to natalizumab had developed an early stage of PML, what factors might have been contributory to the three PML cases that did occur, to consider what procedures could be utilized to potentially decrease the risk of PML in the future, and how to suitably monitor patients to detect a PML infection as early as feasible.
The drug is not being placed back on the market at this time. FDA has scheduled an Advisory Committee Meeting on March 7 and 8, 2006 to discuss an application for Tysabri for use in treating patients with relapsing forms of multiple sclerosis. Aspects for discussion include the risks associated with the drug, its efficacy in the treatment of multiple sclerosis relapses and disability, its possible return to the marketplace, and its proposed risk management plan(s).
For further information, health care professionals and patients can visit FDA's website at: here.
Notice for the Peripheral and Central Nervous System Drugs Advisory Committee meeting: here.
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Anthony H. Risser | neuroscience | neuropsychology | brain
- Business World: Biogen Idec, Elan, Tysabri (natalizumab), And Multiple Sclerosis
From Bloomberg via the New York Times:Move to Reinstate Multiple Sclerosis Drug Published: September 21, 2005 By Bloomberg News Biogen Idec Inc. and the Elan Corporation said yesterday that they would seek federal regulatory approval to resume sales...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab)
From today's Boston Globe:Biogen MS drug gets lift from reports Medical journal suggests Tysabri may make a return By Jeffrey Krasner The Boston Globe 10 June 2005 Biogen Idec Inc.'s drug Tysabri might be safely given to multiple sclerosis patients...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) (cont.)
Additional information in follow-up to this morning's Boston Globe report, from Bloomberg:Elan, Biogen Decline on Report of New Tysabri Illness June 2 (Bloomberg) -- Shares of Elan Corp. and Biogen Idec Inc. tumbled after a fourth possible case of...
- Tysabri (natalizumab): Another Case Of Pml
A third case of progressive multifocal leukoencephalopathy (PML), as reported via The New York Times website: M.S. Drug Tied to a Death Published: March 31, 2005 By Bloomberg News Biogen Idec and the Elan Corporation said that a third patient had developed...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...
Neuroscience
Business World: Biogen Idec, Elan, & Tysabri (Natalizumab) and MS
From the FDA:
FOR IMMEDIATE RELEASE
P06-25
February 16, 2006
Media Inquiries:
Susan Cruzan, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Allows Clinical Studies of Tysabri (natalizumab) for Treatment of MS to Proceed
The Food and Drug Administration (FDA) is reporting that Biogen-IDEC and Elan Corporation announced yesterday that FDA removed the clinical hold on Biogen-IDEC's studies of Tysabri (natalizumab) for patients with multiple sclerosis. This will allow clinical trials to go forward. In February 2005 Biogen-IDEC had announced suspension of marketing and clinical trials after three patients developed progressive multifocal leukoencephalopathy (PML), a frequently fatal infection of the brain, two following treatment with natalizumab for MS, and one patient being treated for Crohn's Disease. Two of these cases were fatal.
The removal of the clinical hold allows patients with MS who were previously treated with the drug under an investigational (IND) study to resume treatment in an IND study following discussion with their physicians about the potential risks and potential benefits of treatment. Although this treatment has been shown to have benefit in patients with relapsing-remitting MS, concern about the risk of PML associated with use of Tysabri remains.
FDA has worked with Biogen-IDEC over the ensuing months to assess whether any other patients exposed to natalizumab had developed an early stage of PML, what factors might have been contributory to the three PML cases that did occur, to consider what procedures could be utilized to potentially decrease the risk of PML in the future, and how to suitably monitor patients to detect a PML infection as early as feasible.
The drug is not being placed back on the market at this time. FDA has scheduled an Advisory Committee Meeting on March 7 and 8, 2006 to discuss an application for Tysabri for use in treating patients with relapsing forms of multiple sclerosis. Aspects for discussion include the risks associated with the drug, its efficacy in the treatment of multiple sclerosis relapses and disability, its possible return to the marketplace, and its proposed risk management plan(s).
For further information, health care professionals and patients can visit FDA's website at: here.
Notice for the Peripheral and Central Nervous System Drugs Advisory Committee meeting: here.
-
Anthony H. Risser | neuroscience | neuropsychology | brain
- Business World: Biogen Idec, Elan, Tysabri (natalizumab), And Multiple Sclerosis
From Bloomberg via the New York Times:Move to Reinstate Multiple Sclerosis Drug Published: September 21, 2005 By Bloomberg News Biogen Idec Inc. and the Elan Corporation said yesterday that they would seek federal regulatory approval to resume sales...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab)
From today's Boston Globe:Biogen MS drug gets lift from reports Medical journal suggests Tysabri may make a return By Jeffrey Krasner The Boston Globe 10 June 2005 Biogen Idec Inc.'s drug Tysabri might be safely given to multiple sclerosis patients...
- Business World: Biogen Idec, Elan, & Tysabri (natalizumab) (cont.)
Additional information in follow-up to this morning's Boston Globe report, from Bloomberg:Elan, Biogen Decline on Report of New Tysabri Illness June 2 (Bloomberg) -- Shares of Elan Corp. and Biogen Idec Inc. tumbled after a fourth possible case of...
- Tysabri (natalizumab): Another Case Of Pml
A third case of progressive multifocal leukoencephalopathy (PML), as reported via The New York Times website: M.S. Drug Tied to a Death Published: March 31, 2005 By Bloomberg News Biogen Idec and the Elan Corporation said that a third patient had developed...
- More M.s. Drug Woes: Avonex And 683699
Biogen and F.D.A. Issue Drug Warning By ANDREW POLLACK The New York Times Published: March 17, 2005 Biogen Idec's multiple sclerosis drug Avonex might cause severe liver damage in rare cases, the company and the Food and Drug Administration said...