Genzyme MS Treatment Cleared in Canada

Health Canada has approved Lemtrada (alemtuzumab) from Genzyme, a Sanofi company, for the management of adult patients with relapsing remitting multiple sclerosis (RRMS), with active disease defined by clinical and imaging features, who have had an inadequate response to interferon beta or other disease-modifying therapies.

Lemtrada’s has a clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up. The Canadian approval was based on data from the Lemtrada clinical development program comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif) in patients with RRMS who had active disease. Approval in Canada follows the recent approval of Lemtrada in the EU. Marketing applications for Lemtrada are also under review in numerous other countries, including the U.S. and Mexico.

Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.