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Lemtrada Receives FDA Approval for MS

11/15/2014

The U.S. Food and Drug Administration approved Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis.

According to the drug's manufacturer, Genzyme, "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." 

The FDA approval of Lemtrada is based on two randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing-remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).

In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up.

For further information, call the MS One to One line at 855-MSOne2One (855-676-6326) Monday through Friday, from 8:30 a.m. – 8 p.m. ET.



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