Results from the panel meeting yesterday.
Original link: http://news.yahoo.com/s/nm/20060308/hl_nm/tysabri_dc
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)