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Biogen Idec's NDA for investigational MS therapy accepted for FDA review

Thursday, May 10 2012 | Comments
Evidence Grade 0 What's This?
The Food and Drug Administration accepted for review Biogen Idec Inc.'s New Drug Application for BG-12 (dimethyl fumarate), an oral therapeutic candidate for the treatment of patients with multiple sclerosis (MS).

The NDA, which Biogen Idec submitted in late February, was supported by a clinical development program in which BG-12 provided significant reductions in MS disease activity, along with a favorable safety and tolerability profile, in two Phase III trials. The FDA is expected to review the marketing application under the standard review timeline.

Biogen Idec is seeking approval of BG-12 in Europe as well, where regulatory authorities also accepted the drug's marketing application for review.

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