After constructive talks with the U.S. Food and Drug Administration or FDA, Sanofi's unit, Genzyme, plans to resubmit in the second quarter its supplemental Biologics License Application or sBLA seeking approval of Lemtrada to treat relapsing forms of multiple sclerosis. The resubmission would provide information to specifically address issues noted by the FDA in its December 27, 2013 Complete Response Letter.
Earlier, Genzyme intended to appeal the FDA's Complete Response Letter. Considering the planned resubmission, the company does not anticipate to pursue an appeal at this time.
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