Ruling on MS Drug Tysabri Delayed
Two companies that make a controversial multiple sclerosis drug said Wednesday that U.S. regulators had delayed for 90 days a decision on whether to permit it back on the market.
Biogen Idec Inc. of Cambridge, Mass., and Elan Corp. of Dublin, Ireland, said in a joint statement that the Food and Drug Administration had postponed until June 28 a decision on whether to re-approve the drug, called Tysabri.
Biogen Idec fell 21 cents to $48.10 on the news. Shares of Elan, Ireland’s biggest drug maker fell 55 cents to $13.80.
Jack Gorman, an analyst at Davy Stockbrokers in Dublin, described the FDA delay as “a marginal negative.” But he said his expectation that Tysabri would return to the market in mid-2006 “remains fully intact.”
In November 2004, the FDA approved Tysabri for sale to the approximately 350,000 people in the United States who suffer from MS, an incurable disease of the central nervous system.
But Elan and Biogen withdrew the drug three months later, after three people taking Tysabri in clinical trials contracted a rare, often fatal brain disease called progressive multifocal leukoencephalopathy, or PML. Two of them died. Both companies subsequently said they found no additional PML cases among Tysabri users.
On March 9, an FDA advisory panel voted unanimously to recommend that the agency allow Tysabri to be sold again in the U.S., subject to new restrictions. The panel cited the drug’s ability to block the recurrence of key MS symptoms, such as sudden partial paralysis.
