PARIS May 30 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
Sanofi had said in April it planned to resubmit its
application for Lemtrada following what it said had been
constructive discussions with the FDA.
By 0705 GMT, Sanofi shares were up 0.21 percent at 78.06
(Reporting by Dominique Vidalon; Editing by David Holmes)