Biogen Idec to attempt Tysabri return
Biogen Idec hopes to regain marketing clearance for its multiple sclerosis drug once labeling is revised to reflect risks.
Chief executive James Mullen told the Associated Press last week that Biogen Idec will recommend that Tysabri carry warnings about three cases of progressive multifocal leukoencephalopathy (PML) discovered after clinical trials. The revised label also would warn that patients with weak immune systems are more susceptible to PML.
Some analysts say strong warnings on the biologic's label could undermine its commercial success. A Morgan Stanley analyst who had obtained a list of adverse events related to Tysabri said the reports show a number of patients died from rare infections after taking Tysabri, which was withdrawn in February.
By the end of this month, Biogen Idec and its Tysabri marketing partner, Elan, plan to submit findings from their review of the drug's safety, Mullen said.
The FDA granted Tysabri an accelerated approval in November based on one-year data from two Phase III studies, both of which had been scheduled to run two years.
Meanwhile, the company plans to cut about 17 percent of its staff to reduce its operating expenses. The job cuts will reportedly come from all departments and all locations.