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Genzyme to Resubmit Lemtrada™ Application for FDA Review

4/7/2014

Genzyme 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, according to a statement issued by the company. The announcement follows what Genzyme calls “constructive discussions” with the U.S. Food and Drug Administration (FDA). 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. 



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