EU approves Lemtrada for Multiple Sclerosis
Sanofi/Genzyme announced that the European Commission has on 17 September 2013 granted marketing authorization for Lemtrada (alemutuzumab). This follows the August 30th approval of Aubagio (oral teriflunomide). The company intends to begin launching both products in the EU soon. This approval is the first for Lemtrada globally.
Lemtrada is indicated for the treatment of adult patients with relapsing remitting Multiple Sclerosis (RRMS) with active disease defined by clinical or imaging features. 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.
BayerHealthCare has exercised its option to co promote Lemtrada.
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