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 United Nations Security Council has long been a bastion for men selected to represent their countries on what is considered to be the Organization's most powerful body. But now, women ambassadors are occupying more than one third of the Council's 15 seats, making history with record representation of the gender. "It's a little strange that it's taken us this long," according to Ambassador Syl Yukiya Amano, Director General of the International Atomic Energy Agency (IAEA), said Monday that nuclear programs of the Democratic People's Republic of Korea (DPRK) and Iran remain matters of serious concern. The head of the United Nations nuclear watchdog made the remarks at the opening of the... Stocks largely turned in a lackluster performance during trading on Monday, as traders looked ahead to the Federal Reserve's monetary policy announcement later this week. Technology stocks saw significant weakness, however, resulting in a sharp drop by the tech-heavy Nasdaq.
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.