RE S E A R C H
Research Round-Up
20
Clinical Trial Shows Promise for New Therapy for Relapsing MS
New MS Drug Application Filed for FDA Review
In a clinical trial involving 1,169 people with relapsingremitting multiple sclerosis, oral teriflunomide reduced relapses compared with placebo over at least 48 weeks. Of two different doses tested, the higher dose also slowed progression of disability. This is the third completed of five phase III studies involving teriflunomide in multiple sclerosis. An application for marketing approval of teriflunomide was accepted for review by the U.S. Food and Drug Administration last fall. These and results from additional studies should help define the short-term safety and promise of teriflunomide as a potential new therapy for relapsing MS.
In June, Genzyme announced that it had submitted a new drug application to the FDA for approval to market alemtuzumab – under the proposed name Lemtrada – for treatment of relapsing MS. The application was based on positive results from several clinical trials involving people with relapsing-remitting MS. Alemtuzumab is given by a cycle of IV infusions only once per year. The FDA review process generally takes from six to 10 months. “People with MS need more treatment options. If the FDA agrees to file this application and its review finds alemtuzumab to be safe and effective, it would represent a significant new treatment advance,” said Dr. Timothy Coetzee, Chief Research Officer of the National MS Society.
MSConnection • FALL 2012