Biogen Idec Says FDA Extends MS Drug Review
Biogen Idec Inc., the third-largest U.S. biotechnology company, said the Food and Drug Administration extended the review of its experimental multiple sclerosis medicine by three months.
The FDA didn’t request more studies of the drug BG-12, the Weston, Massachusetts-based company said in a statement today. The three-month extension is a standard period, Biogen said.
The drug is meant to treat relapsing-remitting MS, the most common form of the illness. The disease affects more than 2.1 million people worldwide and about 400,000 Americans, according to the National Multiple Sclerosis Society. Patients with RRMS get attacks that degrade their neurological function, followed by periods of recovery.
Current therapies include Teva Pharmaceutical Industries Ltd.’s Copaxone and Biogen’s drugs Avonex and Tysabri. Biogen, drew $2.7 billion in sales of Avonex last year and $1.1 billion for Tysabri. Other treatments include Novartis AG (NOVN)’s Gilenya, the first pill approved for the disease; Sanofi (SAN)’s Aubagio, another pill that was approved in September; Bayer AG’s Betaseron and Merck KGaA (MRK)’s Rebif. More treatments are in development.
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