FDA declines approval of Lemtrada for the treatment of MS

March 21, 2014 Pavle Repovic, MD, PhD

On December 30, 2013, the US Food and Drug Administration declined to approve the use of alemtuzumab (Lemtrada) for the treatment of multiple sclerosis. The FDA stated that the manufacturer of Lemtrada “has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects.” This was a surprising decision to some, as only a month earlier an advisory panel of experts convened by the FDA, while raising some objections, voted to have this medicine approved. The manufacturer of Lemtrada, Genzyme, a Sanofi company, intends to appeal this decision.
In response, a number of MS organizations and experts have voiced their concerns that with this step, MS patients are left without a potential choice in therapy. This decision is particularly difficult for the patients who participated in the studies of Lemtrada, including those at the MS Center at Swedish. It also highlights the global differences among regulatory bodies in Europe, Canada and Mexico, where Lemtrada has been approved, and the US. The decision sparked no fewer than 5 editorials among leading neurology journals, pitting those who support Lemtrada’s risk/benefit ratio against its critics.

At this point, it is difficult to predict the outcome of pending appeal to the FDA. Additional studies will be costly, and the company may yet decide to give up on this therapeutic option, much as EMD Serono gave up on cladribine. It is hoped, however, that a sufficient consensus may be reached, perhaps through a carefully controlled risk-monitoring program, that would allow limited availability of this medication for the patients who have exhausted other treatment options.

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