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related to Tysabri said the reports show a number of patients died from rare infections after taking Tysabri, which was withdrawn in February.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.

Next Article in Business Briefs

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Business Briefs

Genentech shift could prove costly for hospitals

Genentech will use specialty distributors rather than wholesalers, hospitals pharmacy directors have learned.

Novartis said to be stepping out of HCV

Novartis is said to have relinquished rights to an investigational hep. C treatment, signaling its exit from the therapeutic space, according to a former partner's announcement.

Monday Moves: September 15

Hires and promotions for manufacturers, regulatory and agencies