Genzyme said that under fast track designation, Alemtuzumab for MS is eligible for priority review and the FDA may consider for review portions of the marketing application before the submission of a new drug application (NDA) is completed.
Alemtuzumab is presently being evaluated in two pivotal multi-center, multi-national trials, known as CARE-MS SM (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis).
Genzyme’s CARE-MS I Phase 3 trial is a randomised study comparing Alemtuzumab to the approved therapy Rebif (high-dose interferon beta-1a) in early, relapsing-remitting multiple sclerosis (RRMS) patients who have received no prior therapy. The second Phase 3 trial, CARE-MS II, is comparing Alemtuzumab to Rebif in RRMS patients who had active disease while on other MS therapies.
Henri Termeer, chairman and CEO of Genzyme, said: “We are extremely pleased that our Alemtuzumab development program has been assigned Fast Track status, and look forward to working closely with the FDA to expedite the program’s review process. Alemtuzumab is a transformative therapy for the treatment of MS.”