Genzyme says Lemtrada sBLA for MS accepted by FDA; reports on Aubagio

French drug major Sanofi (Euronext: SAN) US biotech subsidiary Genzyme says that the US Food and Drug Administration has accepted for standard review the company’s supplemental Biologics License Application (sBLA) file seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The company also reported key highlights from the US launch of once-daily, oral Aubagio (teriflunomide).

Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for Lemtrada to the European Medicines Agency and the review process is underway (The Pharma Letter June 12, 2012). The Committee for Medicinal Products for Human Use (CHMP) opinion for Lemtrada is expected in Q2 2013.  The drug is being developed in collaboration with Germany’s Bayer (BAYN: DE).

$3.5 billion peak sales touted by Genzyme