The US Food and Drug Administration (FDA) has declined approval for alemtuzumab (Lemtrada, Genzyme, a Sanofi Company) for its supplemental Biologics License Application in relapsing-remitting multiple sclerosis (MS).
"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," the company notes in a release. "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. FDA has also taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada
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