EP is a community where members connect through shared life experiences-- like MS--and so much more. You are not defined by any one thing, so be your true self and find others just like you at
Experience Project.
GAITHERSBURG, Maryland (Reuters) - Biogen Idec's (Nasdaq:BIIB - news) multiple sclerosis drug Tysabri should return to the market with safeguards to closely monitor patients for a potentially fatal complication, a U.S. advisory panel unanimously ruled on Wednesday.
Biogen and marketing partner Elan Corp. (NYSE:ELN - news) (ELN.I) voluntarily suspended sales in February 2005 after three patients developed a brain and spinal cord infection known as progressive multifocal leukoencephalopathy, or PML. Two of the patients died.
Members of the U.S.
Food and Drug Administration advisory panel voted 12-0 that Tysabri sales could resume if Biogen creates a mandatory patient registry to track side effects and imposes other controls.
Many patients do not find relief with current MS drugs and should have Tysabri as an option, panel members said.
"Most people in (Tysabri) studies did not have a relapse and did not have disability progression," said Dr. Karl Kieburtz, the panel chairman.
The FDA will make the final decision but usually follows advisory panel recommendations.
The panel voted 7-5 that Tysabri could be considered as a first-choice treatment for some MS patients.
Tysabri is a key drug for both Biogen and Elan. It had been dubbed a billion-dollar-a-year seller before the safety concern arose.
Sanford Bernstein analyst Geoff Porges said after the panel votes that Tysabri sales could reach $700 million a year by 2010.
"There's going to be a real cautionary statement toward patients and physicians, and they're going to think twice about putting patients on the drug. Initially there are going to be a lot of desperate patients who jump on it, but it's probably going to be a slow build.
"This is not going to become a routine drug in the next year or two," he said.
Multiple sclerosis causes progressive disability that can include blurred vision, weakness, poor muscle coordination and loss of memory and mental function as nerves lose their insulating sheath. About 300,000 Americans have MS.
(Additional reporting by Bill Berkrot in New York)
You cannot post new topics in this forum You cannot reply to topics in this forum You cannot edit your posts in this forum You cannot delete your posts in this forum You cannot vote in polls in this forum
We encourage you to also visit our Multiple Sclerosis story and support community on Experience Project.
Experience Project is a vast and powerful community where people connect anonymously through life experiences. It's made by the same people who built This is MS,
on the premise that no one life experience-- like having MS-- defines a person. It now covers over 2 million life stories. Find and share yours!
Forum FAQ
Search
Usergroups
Profile
Log in to check your private messages
Log in
