Sanofi MS Drug Lemtrada Fails to Win Backing of U.S. FDA
This article is for subscribers only.
Sanofi failed to win U.S. regulatory approval for its multiple sclerosis drug Lemtrada, denting the company’s ambitions of capturing a larger share of the $20 billion market for the disease.
The U.S. Food and Drug Administration said Sanofi’s Genzyme unit didn’t submit evidence from “adequate and well-controlled studies” showing that the benefits of Lemtrada outweigh its side effects, the Paris-based company said in a statement today. Sanofi disagrees with the conclusion and said it will appeal.