Genzyme receives Complete Response Letter from FDA on LemtradaTM (alemtuzumab) application

Sanofi and its subsidiary Genzyme has announced that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. A Complete Response Letter informs companies that an application is not 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.

Source: http://feedproxy.google.com/~r/mnt/healthnews/~3/cBF3aluQU30/270696.php

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