New MS drug pulled from the market

http://www.cnn.com/2005/HEALTH/02/28/ms.drug.suspension.ap/index.html

MS drug pulled after patient dies
Monday, February 28, 2005 Posted: 4:46 PM EST (2146 GMT)


BOSTON, Massachusetts (AP) -- The makers of a promising new multiple sclerosis drug announced Monday they are voluntarily pulling the medication from the market after one patient died and another developed a serious disease of the central nervous system.

Experts said the announcement by Biogen Idec Inc. and Elan Corp. marks sad turn of events for MS sufferers who have endured a more than centurylong search for effective treatments for the incurable disease.

The news came three months after the government approved the drug, called Tysabri. Stocks of both Massachusetts-based Biogen Idec Inc. and Ireland-based Elan Corp. tumbled on the announcement.

The companies said they will investigate the effects of the medication further, and they are not giving up hope that the drug may eventually return to the market.

Still, even if the drug never comes back, experts said Tysabri has helped advance research in an area that has seen few successes since MS was first identified in 1868.

"We're disappointed," said Dr. Howard L. Weiner, author of a book on MS and director of the Partners MS Center at Brigham & Women's Hospital in Boston. "But the results that we saw with this drug moved forward our understanding and treatment of MS, and identified an avenue for treatment that is still very much alive."

Multiple sclerosis is a brain disease which can lead to muscle weakness, difficulty concentrating, slurred speech and paralysis. About 400,000 Americans and 2.5 million people worldwide are believed to be affected by MS, which is more common in women than men and often strikes between the ages of 20 and 50, according to the MS Society.

While no cure has emerged, Tysabri has been considered a promising therapy because of its unique approach in blocking the movement of inflammatory cells from the bloodstream into the brain, Weiner said.

In patients with multiple sclerosis, their body's immune system turns rebellious, attacking, inflaming and damaging its own nerve tissue. The most common type of MS involves a worsening, or relapse, of acute symptoms.

The decision to withdraw the drug came after recent reports of two cases of serious effects among patients who used it along with an earlier Biogen Idec MS drug, called Avonex, in clinical trials. In one case, the person died, while in another, the person developed a suspected case of a rare and frequently fatal disease of the central nervous system.

Both patients had taken Tysabri for more than two years in combination with Avonex, the companies said.

Tysabri was approved after a study showed that it reduced MS relapses by 66 percent compared with a placebo. And patients who received Avonex along with Tysabri experienced a 54 percent reduction in relapses over patients using Avonex alone. That drug reached the market in 1996.

About 5,000 patients have received intravenous infusions of Tysabri since its November approval, Biogen executives said.

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