Sanofi (SAN) 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.Lemtrada, which was approved in the European Union in September, was a key part of Sanofi’s $20.1 billion acquisition of Genzyme in 2011. The FDA indicated one or more additional trials comparing Lemtrada with another drug are needed for approval, Sanofi said. That would delay the product’s entry to a market dominated by Teva Pharmaceutical Industries Ltd. (TEVA:US)’s Copaxone, Biogen Idec Inc. (BIIB:US)’s Tecfidera, Avonex and Tysabri, Novartis AG’s (NOVN) Gilenya and Merck KGaA’s Rebif.
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