FDA Grants Priority Review for Sanofi and Regeneron's Drug
January 26 2015 - 2:14AM
Dow Jones News
By Inti Landauro
PARIS--The U.S. Food and Drug Administration has granted a
priority review to evaluate the request to market Praluent, a new
drug intended to treat hypercholesterolemia and developed by
pharmaceutical labs Sanofi (SAN.FR) and Regeneron (REGN), the two
firms said Monday.
The goal of the priority review is to get a decision on the
application to get a biologics license which gives permission to
introduce the drug into interstate commerce, within six months, or
on July 24, the two firms said in a statement Monday.
Earlier this month, the European Medicines Agency accepted for
review a request for market authorization of the drug, also known
as alirocumab, the two companies said.
-Write to Inti Landauro at inti.landauro@wsj.com
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