CHMP recommends Lemtrada (Sanofi/Bayer)to treat relapsing remitting Multiple Sclerosis

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Lemtrada (alemtuzumab) for the treatment of adult patients with relapsing remitting Multiple Sclerosis (RRMS) with active disease defined by clinical or imaging features.

The positive CHMP opinion for approval of Lemtrada was based on data from the CARE-MS I and CARE-MS II trials, in which Lemtrada was significantly more effective than Rebif (subcutaneous interferon beta-1a 44 mcg three times weekly) at reducing relapse rates. In CARE-MS II, accumulation of disability was significantly slowed in patients given Lemtrada vs. Rebif, and importantly, patients treated with Lemtrada were significantly more likely to experience improvement in pre-existing disability.