Sanofi to Resubmit Lemtrada Application to FDA in Second Quarter
April 07 2014 - 3:01AM
Dow Jones News
By Inti Landauro
PARIS--French pharmaceutical giant Sanofi SA (SAN.FR) on Monday
said it will resubmit in the second quarter an application to the
U.S. Food and Drug Administration for its multiple sclerosis
treatment Lemtrada, which received a negative review in November
last year.
Genzyme, the unit of Paris-listed Sanofi which develops
Lemtrada--also known as alemtuzumab--will resend an application to
the FDA to address all the issues raised by the agency.
Genzyme has decided to resubmit the application instead of
appealing the FDA decision as previously announced.
Write to Inti Landauro at inti.landauro@wsj.com
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