FDA approves Genzyme’s Lemtrada to treat multiple sclerosis

The company said that due to its safety profile, the use of Lemtrada should be reserved for patients who have had an inadequate response to two or more drugs indicated to treat MS.

The approval is based on two pivotal randomized Phase III open-label rater-blinded trials comparing treatment with Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS.

Patients participated in these trials were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).

Genzyme president and CEO David Meeker said: "Today’s approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada.

"Lemtrada demonstrated superior efficacy over Rebif on annualized relapse rates in the two studies which were the basis for approval. A comprehensive risk evaluation and mitigation strategy (REMS) will be instituted in order to help detect and manage the serious risks identified with treatment."

In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, while in CARE-MS II the drug was more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was reduced in patients given Lemtrada vs. interferon beta-1a.

In the US, the approval of Lemtrada marks Genzyme’s second MS treatment approval. In September 2012, the company secured approval for its Aubagio (teriflunomide) to treat relapsing forms of MS.

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

Image: Genzyme’s Lemtrada has a new dosing and administration schedule of two annual treatment courses. Photo: courtesy of Baitong333/ freedigitalphotos.net