Genzyme Announces: FDA Accepts Its Resubmitted Application for Lemtrada
May 30, 2014
Today (May 30) Genzyme, a Sanofi company, announced that the U.S. Food and Drug Administration had accepted for review the company’s resubmission of an application seeking 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). According to a company press release, additional analyses and information have been provided to the agency, and the FDA’s review is expected to take about six months.
The Society will continue to provide updates as we learn more information.