Post by Deb on Nov 19, 2005 11:08:09 GMT -5
FDA Agrees to Faster Review of Tysabri
.c The Associated Press
CAMBRIDGE, Mass. (AP) - Federal regulators have agreed to a faster review of an application to resume selling a multiple sclerosis drug removed from the market because of safety concerns, the drug's makers said Thursday.
The Food and Drug Administration's decision to grant a priority review of the drug Tysabri means the agency is expected to act within six months of the application's submission rather than the standard 10 months, Biogen Idec Inc. and Elan Corp. said.
Cambridge-based Biogen Idec and Ireland's Elan submitted the application Sept. 26 to resume selling Tysabri with a revised label and a plan to address patient risks.
The FDA initially approved Tysabri last November.
The drug was withdrawn from the market Feb. 28 despite hopes that it would become an important new tool in treating MS, a debilitating and incurable disease in which the body's immune system attacks, inflames and damages its own nerve tissue.
Biogen Idec has said the revised label Tysabri could carry if it returns to the market could warn about risks for patients with weak immune systems. Such patients could be more susceptible to contracting a disease called progressive multifocal leukoencephalopathy, or PML.
Biogen Idec and Elan withdrew the drug amid fears that it could heighten the risk of contracting PML. The companies confirmed that two MS patients and one sufferer of Crohn's disease, an intestinal disorder, had contracted PML. The Crohn's patient and one of the MS patients died.
Biogen Idec shares plunged more than 42 percent the day the drug was withdrawn, while Elan's stock fell 70 percent.
The application before FDA to resume sales includes data from safety reviews the drug's makers recently completed on more than 3,000 patients who have taken Tysabri. The companies say no new cases of PML were discovered in the reviews.
News of the priority review sent shares of both companies higher. Elan shares surged 8.7 percent, or 90 cents, to $11.20 while Biogen rose 1.7 percent, or 77 cents to $45.85. Earlier, Elan closed at $10.30 on the New York Stock Exchange, while Biogen Idec rose $1.09 to close at $44.81 on the Nasdaq Stock Market.
On the Net:
Biogen Idec: www.biogen.com
Elan: www.elan.com
.c The Associated Press
CAMBRIDGE, Mass. (AP) - Federal regulators have agreed to a faster review of an application to resume selling a multiple sclerosis drug removed from the market because of safety concerns, the drug's makers said Thursday.
The Food and Drug Administration's decision to grant a priority review of the drug Tysabri means the agency is expected to act within six months of the application's submission rather than the standard 10 months, Biogen Idec Inc. and Elan Corp. said.
Cambridge-based Biogen Idec and Ireland's Elan submitted the application Sept. 26 to resume selling Tysabri with a revised label and a plan to address patient risks.
The FDA initially approved Tysabri last November.
The drug was withdrawn from the market Feb. 28 despite hopes that it would become an important new tool in treating MS, a debilitating and incurable disease in which the body's immune system attacks, inflames and damages its own nerve tissue.
Biogen Idec has said the revised label Tysabri could carry if it returns to the market could warn about risks for patients with weak immune systems. Such patients could be more susceptible to contracting a disease called progressive multifocal leukoencephalopathy, or PML.
Biogen Idec and Elan withdrew the drug amid fears that it could heighten the risk of contracting PML. The companies confirmed that two MS patients and one sufferer of Crohn's disease, an intestinal disorder, had contracted PML. The Crohn's patient and one of the MS patients died.
Biogen Idec shares plunged more than 42 percent the day the drug was withdrawn, while Elan's stock fell 70 percent.
The application before FDA to resume sales includes data from safety reviews the drug's makers recently completed on more than 3,000 patients who have taken Tysabri. The companies say no new cases of PML were discovered in the reviews.
News of the priority review sent shares of both companies higher. Elan shares surged 8.7 percent, or 90 cents, to $11.20 while Biogen rose 1.7 percent, or 77 cents to $45.85. Earlier, Elan closed at $10.30 on the New York Stock Exchange, while Biogen Idec rose $1.09 to close at $44.81 on the Nasdaq Stock Market.
On the Net:
Biogen Idec: www.biogen.com
Elan: www.elan.com