US Pharm. 2013;38(12):6.Silver Spring, MD—An FDA advisory committee has recommended approval of alemtuzumab (Lemtrada) for the treatment of relapsing/remitting multiple sclerosis (MS) despite serious adverse effects and concerns of design bias in its clinical trials. In two studies, patients on alemtuzumab were significantly less likely to experience a relapse over the course of 2 years than with other agents. The drug was sold under the trade name Campath as a treatment for leukemia for many years, but commercial sales were halted once alemtuzumab was acquired by Genzyme so that the company could make it available exclusively as an MS treatment. Lemtrada is already approved in Europe, and the FDA is expected to make a final decision later this year.
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