Genzyme, a Sanofi company, received a Complete Response Letter from FDA for its supplemental Biologics License Application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis (MS), the company announced in a press release. FDA states in the letter that additional clinical trials are needed prior to approval, but Genzyme plans to appeal the agency’s decision.
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. Genzyme says that the clinical development program, which was designed to demonstrate how Lemtrada compares against an active comparator as opposed to placebo, provides robust evidence of efficacy and a favorable benefit-risk profile. This evidence was the basis for the approvals of Lemtrada by other regulatory agencies around the world, the company explained in the press release. Lemtrada is approved in the European Union, Canada, and Australia, and additional marketing applications for Lemtrada are under review by regulatory agencies around the world.