U.S. watchdog to review Lemtrada resubmissionOriginally posted at: http://www.reuters.com/article/2014/05/30/sanofi-lemtrada-idUSL6N0OG13O20140530
May 30 (Reuters) – French drug company Sanofi said on Friday the U.S. Food and Drug Administration (FDA) had agreed to review its U.S. unit Genzyme’s resubmission of its application for its Lemtrada drug for the treatment of relapsing forms of multiple sclerosis.
A six-month review period has been assigned for the Lemtrada resubmission and Genzyme expects an FDA action in the fourth quarter, Sanofi said in a statement.
“This resubmission is based on data from the same clinical studies included in the original Biologics License Application … and provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter,” it said.
Sanofi had said in April it planned to resubmit its application for Lemtrada following what it said had been constructive discussions with the FDA.