FDA Accepts Resubmission of sBLA for Sanofi’s LemtradaBy
Sanofi and its subsidiary Genzyme report that FDA has accepted for review the company's resubmission of its supplemental biologics license application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A six-month review period has been assigned for the Lemtrada sBLA. Genzyme expects FDA action on the sBLA in the fourth quarter.
This resubmission is based on data from the same clinical studies included in the original sBLA, and provides supplemental analyses and additional information to specifically address issues previously noted by the FDA in its December 27, 2013 Complete Response Letter. The company resubmitted the sBLA earlier this month following discussions with the agency.