Genzyme files multiple sclerosis drug Lemtrada with FDA and EMA

French drug major Sanofi (Euronext: SAN) subsidiary Genzyme revealed this morning that it has submitted a supplemental Biologics License Application (sBLA) to the US Food and Drug Administration and a marketing authorization application to the European Medicines Agency seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS).

Genzyme is developing Lemtrada in MS in collaboration with Germany’s Bayer (BAYB: D), whose Bayer HealthCare unit retains an option to co-promote alemtuzumab in MS and, on regulatory approval and commercialization, would receive contingent payments based on sales revenue.

$3.5 billion peak sales touted by Genzyme