Sanofi Genzyme Announces it Will Resubmit Lemtrada Application to the FDA
April 7, 2014
Today (April 7) Sanofi Genzyme announced it will be resubmitting its application to the U.S. Food and Drug Administration for approval of Lemtrada™ (alemtuzumab) as a treatment for relapsing MS in the United States. The company’s previous application was denied approval in December 2013 (read more). The company announced it intends to submit during the second quarter of 2014.
“We are encouraged by this development and will be monitoring the process closely as it moves forward,” commented Timothy Coetzee, PhD, Chief Advocacy, Services and Research Officer at the National MS Society.
The Society will continue to provide updates as we learn more information.