Genzyme receives Refuse to File letter from FDA for LEMTRADA

Aug 27 2012

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced it has received a Refuse to File letter from the U.S. Food and Drug Administration (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. Genzyme will work with the FDA over the coming weeks to resubmit the application as soon as possible.

"We have had constructive dialogue with the FDA, and we are very confident in our ability to address the agency's request and resubmit rapidly," said David Meeker, President and CEO, Genzyme.

The company's marketing authorization application submitted to the European Medicines Agency has been accepted and the review process is underway.

Genzyme is developing LEMTRADA in MS in collaboration with Bayer HealthCare.

Source: Genzyme