logo
Plus   Neg
Share
Email

Genzyme Says EMA Accepts Oral Teriflunomide MAA To Treat Multiple Sclerosis

Genzyme, a Sanofi company (SNY), 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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Walmart is ditching its dress code policy and is testing a new dress code that will allows "associates" to wear blue denim and shirts of any solid color. The updated dress coded guidelines now allow employees to wear blue "jeggings" and blue jeans and shirts of any solid color, according to a Walmart... Canadian investment firm Fairfax Financial Holdings Ltd. has submitted a "stalking horse" bid worth C$300 million, or $237 million, for the Canadian unit of Toys "R" Us, according to court documents. A stalking horse bid is an initial bid on the assets of a bankrupt company. The bankrupt company will choose an entity from a pool of bidders who will make the first bid on its assets. The car rental market in the U.S. is consolidating as large car rental companies are buying smaller, local companies to expand their portfolio of premium and value brands. The key players in the U.S. market include Enterprise Holdings, Hertz Global Holding and Avis Budget Group. Let's take a look at some of the best and worst car rental companies in the U.S.
Follow RTT