Reuters
Thursday, March 9, 2006

A panel of independent experts urged the government yesterday to allow the multiple sclerosis drug Tysabri back on the market. The medication was abruptly withdrawn last year after it was linked to a life-threatening side effect.

If the Food and Drug Administration follows the recommendation, it would mark a reversal of fortune for drugmaker Biogen Idec and partner Elan Corp. of Ireland, and a victory for patients who have pleaded for access to the drug.

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 to resume Tysabri sales.

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

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

Many patients do not find relief with current multiple sclerosis drugs and should have Tysabri as an option, panel members said.

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

The FDA will make the final decision but usually follows advisory panel recommendations. A decision is expected this month.