UPDATED: Genzyme Applies to FDA for Approval of Alemtuzumab to Treat Relapsing MS
August 27, 2012
Update January 28, 2012
Update on Genzyme application to FDA for approval of alemtuzumab for treating relapsing MS. Genzyme announced that the FDA accepted the application for review, and that they expect FDA action on the application in the second half of 2013.
Genzyme announced that the company had submitted a New Drug Application to the U.S. Food and Drug Administration for approval to market alemtuzumab (proposed name Lemtrada™) for the treatment of relapsing MS, 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 now has 60 days to decide whether to file it so it can be reviewed; the review process generally takes from 6 to 10 months.
Multiple sclerosis involves immune system attacks against brain and spinal cord tissues. Alemtuzumab is a monoclonal antibody that depletes circulating immune (T and B) cells thought to be responsible for these attacks. In one phase III clinical trial called CARE-MS I, alemtuzumab significantly reduced relapse rates when compared to Rebif® (interferon beta-1a, EMD Serono Inc. and Pfizer). In a second phase III trial called CARE-MS II, alemtuzumab significantly reduced relapse rates and worsening of disability compared to Rebif in a two-year study. Data from the CARE-MS II trial were presented at the 2012 Annual Meeting of the American Academy of Neurology in April.
“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.
Rebif is a registered trademark of EMD Serono, Inc.