Genzyme,
a Sanofi Company 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).
LEMTRADA sBLA Accepted by FDA
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
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