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MS drug Tysabri should return to market: US panel

Posted on: Wednesday, 8 March 2006, 15:07 CST

By Lisa Richwine

GAITHERSBURG, Maryland (Reuters) - A panel of independent experts on Wednesday unanimously urged the U.S. return of Biogen Idec's multiple sclerosis drug Tysabri, a medicine abruptly pulled from the market last year after it was linked to a life-threatening side effect.

If the Food and Drug Administration followed the recommendation, it would signal a reversal of fortune for Biogen and partner Elan Corp. of Ireland, and a victory for MS patients who have pleaded for access to the medicine.

The advisory panel said Tysabri must have mandatory controls to ensure that patients are aware of risks and that any new cases of a possibly fatal brain infection are found quickly. All 12 members voted in favor of resuming Tysabri sales.

Only one prescription drug, GlaxoSmithKline Plc's irritable bowel treatment Lotronex, has returned to the U.S. market after being withdrawn over safety concerns.

Biogen and Elan voluntarily suspended Tysabri sales in February 2005 after three patients developed the infection known as progressive multifocal leukoencephalopathy, or PML. Two of them died.

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. Patients in those studies received monthly infusions of Tysabri for two years.

The panel also voted 7-5 that Tysabri could be considered as an initial treatment for some MS patients, without requiring them to try another therapy first.

The FDA will make the final decision but usually follows advisory panel recommendations. A ruling is expected by the end of the month.

Dozens of MS patients, some in tears, appealed to the panel on Tuesday to let them decide for themselves whether Tysabri's risks were worth taking. They said Tysabri produced dramatic improvements in motor function and should be available as long as patients are told of the risks.

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.

Tysabri is a key drug for Cambridge, Massachusetts-based Biogen and Irish drugmaker Elan. It had been dubbed a billion-dollar-a-year seller before the safety concern arose.

"It's quite a ringing endorsement to get a recommendation to have it back on the market with a unanimous vote," Nomura Code Securities analyst Mike Ward said.

Sanford Bernstein analyst Geoff Porges predicted Tysabri sales of $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.

Biogen has promised restrictions on Tysabri's use aimed at making sure patients know of risks and promptly recognize and report any signs of PML to the company and regulators. In addition to creating a patient registry, the company said it would limit distribution to approved infusion centers.

Older MS drugs cut the number of relapses by one-third, while Tysabri reduced those episodes by two-thirds. Some panel members cautioned, however, that many patients fare well on the older drugs.

Dr. Ralph Sacco, a panel member and neurologist from Columbia University in New York, said he was concerned that Tysabri was "perceived as a wonder drug" and may be overused.

The FDA first approved Tysabri, known generically as natalizumab, in November 2004. About 7,000 patients took the drug before sales stopped.

Trading in Biogen and Elan shares was halted during the panel meeting.

(Additional reporting by Bill Berkrot in New York)

Source: REUTERS

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