Sanofi says U.S. regulators reject MS treatment Lemtrada
PARIS Dec 30 (Reuters) - Sanofi said its Lemtrada multiple sclerosis treatment failed to win approval from U.S. regulators to launch in the world's biggest drug market.
The French firm said it planned to appeal the decision.
The Food and Drug Administration (FDA) "has taken the position that (Sanofi unit) Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects," Sanofi said in a statement on Monday.
"FDA has also taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada."
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