Genzyme plans re submission at FDA for Lemtrada for MS
Genzyme, a Sanofi company announced today that following constructive discussions with the FDA 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 issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. Genzyme had previously announced its intention to appeal the FDA�s Complete Response Letter. In light of the planned resubmission, the company does not expect to pursue an appeal at this time.
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.