Posted on 02/15/2006 10:35:38 PM PST by neverdem
The Food and Drug Administration said yesterday that it would allow some patients in a clinical trial to resume treatment with Tysabri, a multiple sclerosis drug that was abruptly withdrawn from the market a year ago because of safety risks.
The decision appears to strengthen the probability that Tysabri, developed by Biogen Idec and Elan, will be allowed to return to the market. The F.D.A. is scheduled to decide on that question by the end of March.
"You can certainly deduce that we've concluded that there are at least some people for whom the risk is worth it," Dr. Robert Temple, director of medical policy for the drug division of F.D.A., said in an interview.
Still, he said, the decision yesterday was to allow the drug to be used only under the controlled conditions of a clinical trial and only by patients who had previously benefited from it in a clinical trial. "That's not at all the same as making it available for marketing," he said.
Shares of Biogen gained $1.34 on the news, closing at $45.72, an increase of 3 percent. Shares of Elan rose 44 cents, or 3.1 percent, to close at $14.54.
Tysabri, considered a big advance in treatment, was approved in November 2004 and withdrawn from the market by its manufacturers three months later after two patients developed a rare brain disease and one of them died. A third case of the disease, also fatal, was later discovered to have occurred in a patient who had taken the drug in a clinical trial for Crohn's disease.
The brain disease, progressive multifocal leukoencephalopathy, or P.M.L., is caused by a virus.
Biogen and Elan said in a statement yesterday that they planned to initiate a trial in which patients would be monitored for P.M.L. and other side effects.
(Excerpt) Read more at nytimes.com ...
Wonder how many lawyers were involved with this? Thats where your health care $$ are going, folks.
What's the Ph.D. drug then?
I was stupid to sell my Elan stock at 8.75 (though I got it at 1.23).
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FReepmail me if you want on or off my health and science ping list. Anyone can post any unrelated, unposted link as they see fit.
Investing in biotechs is like holding a time bomb. You never know when one is going to explode.
F.D.A. Allows Some Patients to Resume M.S. Drug
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How nice of them.
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