FDA Needs More Data for Lemtrada in MS Trials

Genzyme, a Sanofi company, announced that it has received a Complete Response Letter from the FDA for its supplemental Biologics License Application for Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

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The FDA stated that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh the serious adverse effects. Also, the FDA has taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the Agency’s approval of Lemtrada.

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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