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The U.S. Food and Drug Administration has granted “Fast-Track” status for a Biogen drug target for multiple sclerosis. Biogen is currently enrolling patients in a Phase 3 clinical trial for the drug, called PEGylated interferon beta-1a (BIIB017). The company plans to enroll 1,200 patients in the study.
The study will evaluate the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population. Many multiple sclerosis patients currently take weekly shots of medication.
The FDA’s Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
Biogen currently has two drugs on the market for the treatment of MS, Tysabri and Avonex. In June, the company’s stock dropped after news of a tenth patient taking Tysabri had been diagnosed with a potentially fatal brain infection called progressive multifocal leukoencephalopathy, or PML. In addition, on July 1, Biogen received the rights to commercialize a multiple sclerosis drug outside the U.S. from Acorda Therapeutics.
Biogen Idec stock (Nasdaq:BIIB) was trading at $45.33 in mid-morning trading on Wednesday, up from the previous close of $44.49 at the previous close.
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