FDA accepts application for Genzyme MS drug

Drug maker expects decision on Lemtrada in second half of 2013

CAMBRIDGE, Mass. — The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

Genzyme, a division of French drug maker Sanofi, said the FDA accepted its application seeking approval for Lemtrada (alemtuzumab) for relapsing MS. The company expects the agency to decide whether to approve the drug in the second half of this year.

The company also announced early data about its oral MS drug Aubagio (teriflunomide). According to the company, more than 80% of MS specialists have prescribed the drug, while about 1-in-5 patients prescribed the drug had never received MS treatment before, and more than 50% of those taking it were most recently taking Teva Pharmaceutical Industry's Copaxone (glatiramer acetate) or Biogen Idec's Avonex (interferon beta-1a).


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