Sanofi/Genzyme files Lemtrada at FDA for treatment of Multiple Sclerosis
Sanofi and its subsidiary Genzyme announced that the FDA has accepted for review the company�s supplemental Biologics License Application file seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing Multiple Sclerosis.
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 Committee for Medicinal Products for Human Use opinion for Lemtrada is expected in Q2 2013.
Congress coverage of ACTRIMS/AAN, ECTRIMS, MS Medical Grand Rounds, triMS, ECF and EAN on topics including quality of life in relapsing multiple sclerosis (RMS), safety and efficacy of therapies, pregnancy planning in MS and real-world data of disease-modifying therapies (DMTs).
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