FDA Approves New IV Therapy for Relapsing MS

Genzyme announced that the Food and Drug Administration (FDA) has approved Lemtrada (alemtuzumab) injection for the treatment of patients with relapsing forms of multiple sclerosis (MS).

The approval is supported by two randomized Phase 3 open-label rater-blinded studies (n=1500) that compared Lemtrada to Rebif (high-dose interferon beta-1a; EMD Serono) treatment in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on previous therapy (CARE-MS II).

In the CARE-MS I trial, treatment with Lemtrada resulted in lower annualized relapse rates than with Rebif. The difference in slowing disability progression, however, did not reach statistical significance. In the CARE-MS II trial, treatment with Lemtrada resulted in lower annualized relapse rates than Rebif, and accumulation of disability was significantly slowed in the Lemtrada group vs. Rebif group.

RELATED: FDA Accepts for Review Resubmitted Lemtrada sBLA

Lemtrada is available through a restricted distribution program (Lemtrada REMS). The REMS is based on a risk management program to allow for early detection and management of some of the serious risks associated with Lemtrada.

Lemtrada is available as single-use vials that deliver 12mg/1.2mL (10mg/mL).

For more information call (800) 745-4447 or visit Genzyme.com.

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