CAMBRIDGE, Mass. The Food and Drug Administration has agreed to speed up the review of a Genzyme drug in late-stage development as a treatment for multiple sclerosis, the drug maker said Monday.
The FDA gave fast-track designation to Campath (alemtuzumab), in phase 3 clinical trials as a treatment for patients with relapsing-remitting MS who have not taken therapies before and for those who have had active MS while taking other therapies. The FDA’s fast-track program is designed to expedite review of drugs for serious illnesses that the agency views as having potential to address unmet medical needs. The drug already has FDA approval as a treatment for leukemia.
“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,” Genzyme CEO Henri Termeer said. “Alemtuzumab is a potentially transformative therapy for the treatment of multiple sclerosis and an important part of our future.”