Genzyme has announced that the first US patients have initiated treatment with Lemtrada (alemtuzumab) in the commercial setting following its FDA approval for the treatment of patients with relapsing forms of multiple sclerosis (MS).
Christopher LaGanke, founder of North Central Neurology Associates in Cullman, USA, wasthe first physician to initiate patient treatment in the US.
Lemtrada has a 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.
The FDA approval of Lemtrada was based on two pivotal randomised phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).
In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualised relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada compared to those given interferon beta-1a. The clinical development program for Lemtrada involved nearly 1,500 patients with more than 6,400 patient-years of safety follow-up.
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.