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Sales Of New MS Drug Suspended
- FDA Approved Drug In November
The makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.
Stocks of both Biogen Idec Inc. and Elan Corp. tumbled.
The biotechnology companies said in a news release that they have suspended supplying and marketing the drug and advised doctors to suspend prescribing it. The companies also have stopped using the drug in clinical trials.
The Food and Drug Administration approved Tysabri, which was called Antegren during clinical trials, in November in an accelerated process after a late-stage study showed that it reduced MS relapses by 66 percent compared with a placebo.
About 5,000 patients have received intravenous infusions of Tysabri since the drug’s approval, Biogen executives said during a conference call Monday.
Elan chief executive Kelly Martin told reporters in Ireland, where the company is based, that the drug has been withdrawn as a precaution and that the companies hoped to resume marketing of Tysabri later this year.
The companies said the decision came after recent reports of two cases of serious effects among patients who used the drug along with Avonex, Biogen Idec’s earlier MS treatment, in clinical trials. A study had showed that it improved the performance of Avonex significantly compared with Avonex alone.
In one case, the patient died, while in another, the person developed a suspected case of a rare, frequently fatal disease of the central nervous system called progressive multifocal leukoencephalopathy.
Both patients had taken Tysabri for more than two years in combination with Avonex, the companies said.
“Because we believe in the promising therapeutic benefit of Tysabri, we are working to evaluate this situation thoroughly and expeditiously,” said Dr. Burt Adelman, executive vice president of Development at Biogen Idec, which is based in Cambridge. “While we work through this matter, we must place patient safety above all other considerations.”
The companies said they took the action after consulting with the FDA. Phone messages to the FDA were not immediately returned Monday.
Multiple sclerosis, which has no known cure, attacks and damages nerve tissue, leaving people tired and numb with poor coordination and blurred vision. Relapses can come without warning, affecting vision or rendering a limb useless.
Tysabri—which also is known by the generic name natalizumab— was designed principally to slow the progression of disabilities related to MS, but Elan and Biogen had said they believed it could also help sufferers of Crohn’s disease, a painful bowel disorder, and rheumatoid arthritis.
A special hotline has been set up. Call 1-800-456-2255 for more information.
Biogen shares fell $27.23, or more than 41 percent, to $39.55 in morning trading on the Nasdaq Stock Market, while Elan shares sank $17.90, or more than 66 percent, to $9 on the New York Stock Exchange. Those are the lowest prices for both stocks since late 2003.
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The makers of Tysabri, a new drug used to treat multiple sclerosis, announced Monday they are voluntarily suspending sales of the drug after one patient died and another developed a serious disease of the central nervous system.