January 25, 2006
FDA to decide on fate of MS drug
The FDA will convene a panel of outside experts March 7 to decide whether to allow multiple sclerosis drug Tysabri (natalizumab) back on the market.
The agency said the panel will discuss Tysabri’s “possible return to market and risk management plans,” according to a report in Dow Jones Newswires.
The drug’s marketers, Biogen Idec and Elan, removed Tysabri in February from the US market after two patients developed a rare brain disorder, called progressive multifocal leukoencephalopathy (PML), and one died. In subsequent studies of the drug for Crohn’s disease, a third was found to have PML.
Executives from the companies expect a final ruling from the FDA by the end of March. If it is allowed to return to market, Tysabri’s label likely would have to include a warning that its use has been linked to PML.
This week Biogen Idec and Elan said a recently completed safety evaluation of more than 3,000 Tysabri patients yielded no new confirmed cases of PML.