Sanofi to resubmit Lemtrada application for FDA review
PARIS, April 7
PARIS, April 7 (Reuters) - Sanofi said it plans to resubmit its application for its Lemtrada drug for the treatment of relapsing forms of multiple sclerosis following "constructive discussions" with the U.S. Food and Drug Administration.
The resubmission is expected in the second quarter and will provide information to address issues previously raised by the FDA in December, Sanofi said in a statement on Monday.
Sanofi's Genzyme unit in the United States had previously announced its intention to appeal the FDA's response on Lemtrada.