European Commission OKs Genzyme's Multiple Sclerosis Treatment Lemtrada

By RTT News, September 17, 2013, 01:20:00 AM EDT

(RTTNews.com) - Genzyme, a Sanofi company (SNYNF, SNY) reported that the European Commission has granted marketing authorization for its multiple sclerosis treatment, Lemtrada, following the August 30th approval of Aubagio. Both the products are being planned to launch in the EU soon.

Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis or 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 through intravenous infusion on five consecutive days, while the second course is administered on three consecutive days, a year later.

The Lemtrada clinical development program included two pivotal randomized Phase III trials comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study.

According to the company, in CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not meet statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada versus interferon beta-1a.

FDA action on Genzyme's supplemental Biologics License Application seeking U.S. approval of Lemtrada for relapsing multiple sclerosis treatment is expected in late 2013. Further, Lemtrada is under review by other regulatory agencies. Aubagio is approved to treat relapsing MS in the U.S., Australia, Argentina, Chile, and South Korea, and is under review by additional regulatory agencies.

LEMTRADA has been in active clinical development for MS for over 10 years, with the clinical development program involving more than 1,700 patients.

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European Commission OKs Genzyme's Multiple Sclerosis Treatment Lemtrada