FDA Accepts for Review Resubmitted Lemtrada sBLA

Genzyme announced that the FDA has accepted for review the resubmission of its supplemental Biologics License Application (sBLA) for Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

The 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 constructive discussions with the agency.

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Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in multiple sclerosis.

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