Market Overview

Genzyme's LEMTRADA Application for MS Accepted for Review by FDA

a Sanofi Company (NYSE: SNY), announced that
the U.S. Food and Drug Administration (FDA) has accepted for review the
company's supplemental Biologics License Application (sBLA) file seeking
approval of LEMTRADA (alemtuzumab) for the treatment of relapsing
multiple sclerosis (RMS). The company also reported key highlights from
the U.S. launch of once-daily, oral AUBAGIO (teriflunomide).


The FDA has accepted for standard review the company's sBLA file seeking
approval of LEMTRADA. Genzyme expects FDA action on the application in
the second half of 2013. Genzyme has already submitted its marketing
authorization application for LEMTRADA to the European Medicines Agency

See full press release

Posted-In: News Guidance Contracts Management Global


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