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.
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.