Genzyme receives Refusal to File Letter from FDA relating to Lemtrada application for Multiple Sclerosis

Genzyme has received a Refuse to File letter from the FDA in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing Multiple Sclerosis. After collaborative consultations with the FDA, the agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the application. The FDA has not requested additional data or further studies. The company�s marketing authorization application submitted to the European Medicines Agency has been accepted and the review process is underway.