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Sanofi and Genzyme to resubmit FDA application for approval of Lemtrada, for the treatment of relapsing forms of multiple sclerosis.
Sanofi and its subsidiary Genzyme reported that the company plans to resubmit 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 noted by the FDA in its Dec. 27, 2013 Complete Response Letter.
Genzyme had previously announced its intention to appeal the FDA's Complete Response Letter. As a result of the planned resubmission, the company does not expect to pursue an appeal at this time.