Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Genzyme Gets Complete Response Letter From FDA On Lemtrada Application

RELATED NEWS
Trade SNY now with 

Genzyme, a Sanofi company (SNY: Quote, SNYNF.PK), said it has received a Complete Response Letter from the U.S. Food and Drug Administration or FDA for its supplemental Biologics License Application seeking approval of Lemtrada or alemtuzumab for the treatment of relapsing forms of multiple sclerosis. Alemtuzumab is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells.

A Complete Response Letter informs companies that an application is not yet ready for approval. FDA has taken the position that Genzyme has not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. Genzyme understands that the conclusion is related to the design of the completed Phase 3 active comparator studies of Lemtrada in relapsing-remitting MS patients. Moreover, FDA has taken the position that one or more additional active comparator trials of different design and execution are needed prior to the Lemtrada approval.

Genzyme strongly disagrees with the FDA's conclusions and intends to appeal the agency's decision.

Lemtrada is approved in the European Union, Canada, and Australia, and additional marketing applications for Lemtrada are under review by regulatory agencies worldwide. Sanofi does not expect that the CVR milestone of U.S. approval of Lemtrada by March 31, 2014 would be met.

Register
To receive FREE breaking news email alerts for Sanofi and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
The Swiss economy stalled in the second quarter as the improvement in household spending was insufficient to offset the weakness in exports and investment in construction. Gross domestic product remained flat from the first quarter, when it accelerated to 0.5 percent, the State Secretariat for Economic Affairs said Tuesday. Economists had expected GDP to rise 0.5 percent in the second quarter. Policymakers of Reserve Bank of Australia decided to maintain its record low interest rate once again as they continue to assess that the most prudent course is a period of stability in interest rates. The monetary policy board retained the cash rate at 2.50 percent. The rate has been at the current level since August 2013. A ban on athletes using stamina-boosting gases - xenon and argon - came into effect on Monday. The World Anti-Doping Agency (WADA) said Hypoxia-Inducible Factor (HIF) activators Xenon and Argon have been added to the 2014 List of Prohibited Substances and Methods List following the required three-month notice period and UNESCO's communication to all States Parties. A recommendation to revise the
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.