Sanofi Filing for Lemtrada MS Drug Accepted for Review by FDA
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The U.S. Food and Drug Administration accepted Sanofi’s application for approval of the multiple sclerosis drug Lemtrada, five months after rejecting an initial filing because of the way data was formatted.
Sanofi’s Genzyme unit expects a decision by the agency in the second half of the year, the Paris-based company said in a statement today. The FDA refused to accept the first Lemtrada filing and asked that the company modify the presentation of data to allow regulators to “better navigate the application,” Sanofi said Aug. 27.