Genzyme to resubmit Lemtrada NDA for FDA review

Genzyme, the biotech subsidiary of French drug major Sanofi (Euronext: SAN), said this morning that, following “constructive discussions” with the US Food and Drug Administration, the company plans to resubmit in the second quarter its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

The resubmission will provide information to specifically address concerns noted by the FDA in its December 27, 2013, Complete Response Letter, was issued despite an advisory panel vote recommending approval of the MS drug a month earlier (The Pharma Letter, November 14 and December 30, 2013).

FDA had called for further clinical trials