Genzyme Resubmits Lemtrada to the FDA
Genzyme, a Sanofi company announced today that they will resubmit its supplemental Biologics License Application (sBLA) for approval of Lemtrada (alemtuzumab) for relapsing forms of multiple sclerosis, according to a press release issued by Genzyme. Following discussions with the Food and Drug Administration (FDA), Genzyme intends to submit the application, addressing issues previously noted by the FDA in its Complete Response Letter. Genzyme plans to resubmit the application during the second quarter of 2014.
The Multiple Sclerosis Association of America’s Chief Medical Officer Dr. Jack Burks says, “This is a welcome sign that the FDA and Genzyme are working together to evaluate the issues in the best interest of people with multiple sclerosis.”
For more information on Lemtrada, please visit http://mymsaa.org/news/lemtrada-denied-approval.