FDA Denies Approval for Lemtrada™ (alemtuzumab) for Relapsing MS
January 24, 2014
UPDATED - originally posted December 30, 2013
The U.S. Food and Drug Administration has denied approval at this time for Lemtrada™ (alemtuzumab, Genzyme, a Sanofi Company) as a therapy for relapsing MS. According to a company press release, the FDA has taken the position that one or more additional clinical trials would be needed for marketing approval of Lemtrada. The company plans to appeal the agency’s decision.
Lemtrada is given by infrequent intravenous infusion – for 5 days initially and for 3 days one year later. Details regarding its potential benefits and risks from two phase III trials can be found here. Lemtrada is currently approved in Europe, Canada and Australia.
“This is disappointing news, given the need for more therapeutic options for people with MS living in the United States,” stated Timothy Coetzee, PhD, Chief Advocacy, Services and Research Officer at the National MS Society.
During a November FDA advisory committee meeting about Lemtrada, the committee heard public testimony from people living with MS and patient advocacy groups, including the National MS Society. The Society’s testimony addressed the need for more therapeutic options for people with MS and the importance of empowering people with MS to make their own informed treatment decisions.
The Society will continue to monitor this process and update its constituents of any news.
The Society believes it is important for people with MS to have a voice in their own clinical care, and we also believe it’s important for the Society not to be a filter in the expression of that voice. Individuals and groups impacted by MS who want to reach out directly to the FDA to express their views about this decision can do so according to the FDA by sending an email to firstname.lastname@example.org. We’ve also been informed that copies of these communications should go to Congressional representatives.