Sanofi's Lemtrada garners EU approval for multiple sclerosis

Sanofi's Genzyme unit announced Tuesday that the European Commission approved Lemtrada (alemtuzumab) for the treatment of adults with relapsing remitting multiple sclerosis (RRMS) whose active disease is defined by clinical or imaging features. Genzyme CEO David Meeker commented "this is particularly exciting as the EU approval is the first for Lemtrada globally."

The decision follows a positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in June and was based on results from two Phase III trials. Genzyme noted that in the CARE-MS I and CARE-MS II studies, Lemtrada was significantly more effective than Merck KGaA's Rebif (interferon beta-1a) at reducing annualised relapse rates. In addition, in the second trial, accumulation of disability was significantly slowed in patients given Lemtrada, compared with Rebif.

Genzyme said Lemtrada is administered over two annual treatment courses, with the first course delivered via intravenous infusion on five consecutive days. The second course is administered on three consecutive days, 12 months later.

In August, the European Commission approved Genzyme's Aubagio (teriflunomide) for the treatment of adults with RRMS. The company noted that it plans to launch the once-daily oral therapy, along with Lemtrada, in the EU soon. Aubagio was cleared by the FDA last year, and the US regulator is expected to make a decision on whether or not to approve Lemtrada in late 2013.

For related analysis, see ViewPoints: With European approval likely imminent, have expectations been reset for Sanofi's MS treatment Lemtrada.

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