FDA calls on Genzyme to re-file Lemtrada sBLA

French drug major Sanofi (Euronext: SAN) revealed yesterday that its US biotech subsidiary has received a Refuse to File letter from the Food and Drug Administration in response to the supplemental Biologics License Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis, a pivotal factor in Sanofi raising its offer price for Genzyme to $74 a share (a total of $20.1 billion) from $69 plus a contingent value right largely relating to approval in the MS indication (The Pharma Letter February 16, 2011).

Although the FDA has not requested additional data or further studies, the agency has asked that the company modify the presentation of the data sets to enable the agency to better navigate the application. 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 chief executive of Genzyme.