Genzyme MS Drug Gets Fast Track

Genzyme’s alemtuzumab treatment for multiple sclerosis has been granted Fast Track status by the FDA. This designation covers patients with relapsing-remitting forms of the disease.

The Fast Track program is designed to expedite the review of new drugs that are intended to treat serious or life-threatening conditions and demonstrate the potential to address unmet medical needs. It makes alemtuzumab for MS eligible for Priority Review and the FDA may consider for review portions of the marketing application before the NDA is completed.

“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,” said Henri Termeer, Genzyme’s chairman and chief executive officer. “Alemtuzumab is a potentially transformative therapy for the treatment of multiple sclerosis, and an important part of our future.”

Alemtuzumab is currently being evaluated in two Phase III trials, comparing it to Rebif in early, relapsing-remitting multiple sclerosis (RRMS) patients who have received no prior therapy, and in RRMS patients who had active disease while on other MS therapies. Both trials are fully enrolled and data are expected to be available in 2011.