FDA Approves Sanofi’s MS Drug LemtradaBy
The US Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) for the treatment of patients with relapsing forms of multiple sclerosis (MS). 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.
Lemtrada has a unique dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
First approved in September 2013 in the European Union, Lemtrada is approved in more than 40 countries. Additional marketing applications for Lemtrada are under review by additional regulatory agencies.
The FDA approval of Lemtrada marks Genzyme's second MS treatment approval in the United States. Genzyme, a subsidiary of Sanofi, received FDA approval of its once-daily, oral Aubagio (teriflunomide) for the treatment of relapsing forms of MS in September 2012. Aubagio is approved in more than 50 countries and is under review by additional regulatory agencies.