Biogen Idec to attempt Tysabri return

Share this article:
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related to Tysabri said the reports show a number of patients died from rare infections after taking Tysabri, which was withdrawn in February.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.
Share this article:
You must be a registered member of MMM to post a comment.
close

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

Apple selfies spur diabetes donations

Jazz apples has launched a Crunch to Contribute campaign to raise money for one of two diabetes associations.

Baxter seeks Cambridge, Mass. HQ

Illinois may be tempted to offer tax incentives for the firm to stay put.

FDA wants Alexion to clean up

FDA inspectors have cited the manufacturer of the rare-disease drug Soliris (eculizumab) for poor manufacturing practices.