FDA Asks Genzyme Corporation (GENZ) to Redo Lemtrada Marketing Application
8/27/2012 7:51:07 AM
French pharmaceutical group Sanofi SA Monday said the U.S. Food & Drug Administration has asked the group to refile its application for approval of its Lemtrada drug, which aims to treat relapsing forms of multiple sclerosis. The FDA asked Sanofi's unit Genzyme to modify the presentation of the data sets "to enable the agency to better navigate the application" for Lemtrada, also known as alemtuzumab, Sanofi said in a statement. The French group said it would work with the FDA in the coming weeks to resubmit the application "as soon as possible".