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Biogen Idec Inc. may face a tough day, following the U.S. Food and Drug Administration approval of the first ever treatment for multiple sclerosis in pill form, called Gilenya. The drug approval is considered to be a watershed moment in the treatment of the disease. Until now, patients have had to go to the hospital for periodic infusions.
Analysts say the approval of the novel once-a-day oral therapy, owned by Novartis (Nasdaq:NVS), poses a real threat to Biogen’s MS franchise, which includes the blockbuster drugs Tysabri and Avonex.
The Cambridge-based biotech company issued a statement about the approval, which read in part:
“MS impacts each person differently and, until we have a cure, there should be multiple treatments available to address the individual needs of patients. Today, Biogen Idec is pleased to provide leading MS therapies Avonex and Tysabri, both of which have been used in a broad range of patients worldwide.”
Biogen (Nasdaq:BIIB) pointed out that it has three late-stage clinical drug candidates designed to treat MS. The company is expecting data from a Phase 3 oral drug candidate next year.
Biogen officials warned that the long-term safety profile of Gilenya has yet to be established. A statement from the company read: “We agree with the FDA that there is a need for safety monitoring for Gilenya through a comprehensive Risk Evaluation and Mitigation Strategy.”
EMD Serono, based in Rockland, is also developing an oral MS drug target.
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