FDA issues Complete Response Letter for Lemtrada for Multiple Sclerosis- Genzyme/Sanofi

Sanofi and its subsidiary Genzyme announced that it has received a Complete Response Letter from the FDA for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of Multiple Sclerosis. A Complete Response Letter informs companies that an application is not ready for approval.The FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Genzyme understands that the conclusion is related to the design of the completed Phase III active comparator studies of Lemtrada in relapsing-remitting MS patients. 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. Genzyme strongly disagrees with the FDA�s conclusions and plans to appeal the agency�s decision.