logo
Share SHARE
FONT-SIZE Plus   Neg

Genzyme Says EMA Accepts Oral Teriflunomide MAA To Treat Multiple Sclerosis

Genzyme, a Sanofi company (SNY: Quote), announced the European Medicines Agency, or EMA, has accepted the filing of the marketing authorization application, or MAA, for once-daily oral teriflunomide for the treatment of relapsing forms of multiple sclerosis, or MS.

The company noted that the purpose of the MAA is to secure approval to market and allow prescription of teriflunomide in the European Union based on data from two completed pivotal Phase III trials, TEMSO and TENERE. These trials represent two of five efficacy studies of teriflunomide in MS that are completed or underway, making the clinical program one of the largest and broadest of any MS therapy in development.

An application to market teriflunomide in the United States is under review by the U.S. Food & Drug Administration.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Deutsche Bank (DB) on Sunday reported an about 50 percent decline in first-quarter profit, despite clocking double-digit revenue growth, as the German lender recorded hefty legal charges over allegations of rate-rigging. In a statement, the bank said its results were hurt by litigation expenses of... Casino operator Wynn Resorts said its shareholders ousted Elaine Wynn from the board, reflecting fears that her presence may lead to disharmony with the management. To commemorate the launch of Hubble telescope twenty-five year ago, NASA unveiled celestial fireworks as official image, marked by brilliant tapestry of young stars flaring to life.
comments powered by Disqus
RELATED NEWS
Trade SNY now with 
Follow RTT