By William Horobin
PARIS--The Food and Drug Administration has accepted for review
Sanofi SA's (SAN.FR) new drug application for the French company's
diabetes drug Toujeo, paving the way for a decision on marketing
the drug in the U.S. in the first half of 2015, the French company
said.
"By reaching this key milestone in the approval process, we are
pleased to take another step forward with Toujeo," Sanofi's vice
president for global diabetes, Pierre Chancel, said in a
statement.
The acceptance for review of the new drug application follows
the results of a worldwide series of Phase 3 studies on the
efficacy and safety of Toujeo in 3,500 people, Sanofi said.
The European Medicines Agency has already accepted Sanofi's
marketing authorization dossier for Toujeo, Sanofi said
"With the FDA's acceptance of our submission, we are
anticipating the regulatory decision for marketing authorization
for Toujeo in the U.S. in the first half of 2015," Mr. Chancel
said.
-Write to William Horobin at william.horobin@wsj.com
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