FDA Denies Approval for Lemtrada™ (alemtuzumab) for Relapsing MS
December 30, 2013
The U.S. Food and Drug Administration has denied approval at this time for Lemtrada™ (alemtuzumab, Sanofi Genzyme) 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 (link to Dec 30 2013 press release) 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.