Alemtuzumab (Lemtrada) Approved by FDA

Earlier this month, the US Food and Drug Administration (FDA) approved alemtuzumab (Lemtrada, Genzyme, a Sanofi Company) for the treatment of relapsing forms of multiple sclerosis (MS). A company statement says that because of its safety profile, “the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.” Alemtuzumab (Lemtrada), 12 mg, is given in two annual treatment courses, the first as an intravenous infusion delivered over 5 consecutive days, and the second over 3 consecutive days 12 months later. The company explains the drug is only available through a restricted distribution program, the Lemtrada REMS (Risk Evaluation and Mitigation Strategy). "The program is intended to help educate healthcare providers and patients on the serious risks associated with Lemtrada and the appropriate periodic monitoring required to support the detection of these risks for 48 months after the last infusion," it says. “We at the RMMSC are quite familiar with Lemtrada since we have been part of the clinical research teams for over 10 years,” said Dr. Timothy Vollmer, RMMSC Medical Director and Co-Director of RMMSC at Anschutz Medical Campus, “It is a drug with efficacy on par with Gilenya and Tysabri.  It will be useful when we need to use a powerful drug and patients have risk issues that preclude the use of our other two most powerful therapies. With good safety monitoring, Lemtrada can be used safely.”