Sanofi: FDA to Review New Drug Application for Toujeo

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.

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