Genzyme, a Sanofi company (SNY,SNYNF.PK), said it has received a Complete Response Letter from the U.S. Food and Drug Administration or FDA for its supplemental Biologics License Application seeking approval of Lemtrada or alemtuzumab for the treatment of relapsing forms of multiple sclerosis. Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells.
A Complete Response Letter informs companies that an application is not yet ready for approval. FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Genzyme understands that the conclusion is related to the design of the completed Phase 3 active comparator studies of Lemtrada in relapsing-remitting MS patients. Moreover, FDA has taken the position that one or more additional active comparator trials of different design and execution are needed prior to the Lemtrada approval.
Genzyme strongly disagrees with the FDA's conclusions and intends to appeal the agency's decision.
Lemtrada is approved in the European Union, Canada, and Australia, and additional marketing applications for Lemtrada are under review by regulatory agencies worldwide. Sanofi does not expect that the CVR milestone of U.S. approval of Lemtrada by March 31, 2014 would be met.
by RTT Staff Writer
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