Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

Bayer Submits Application For EU Marketing Authorization For Xarelto

Bayer HealthCare, a subgroup of Bayer AG (BYR.L,BAYRY.PK,BAYZF.PK), said it has submitted an application for marketing authorization to the European Medicines Agency for the oral anticoagulant Xarelto (rivaroxaban) for the treatment of pulmonary embolism, or PE, and the prevention of recurrent deep vein thrombosis and PE in adults.

The submission is supported by data from the pivotal, global Phase III EINSTEIN-PE study. The EINSTEIN-PE study compared the oral single-drug approach of rivaroxaban 15 mg twice daily for three weeks followed by 20 mg once daily with the current standard of care, subcutaneous enoxaparin followed by a VKA.

According to the company, Rivaroxaban demonstrated efficacy comparable to that of the current standard therapy in reducing the primary endpoint of recurrent symptomatic Venous Thromboembolism, or VTE, a composite of symptomatic deep vein thrombosis and non-fatal or fatal PE. The overall bleeding rates were similar between the treatment groups, but importantly rivaroxaban was associated with significantly lower rates of major bleeding.

Click here to receive FREE breaking news email alerts for Bayer AG and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Stocks saw some volatility following the release of the Federal Reserve's monetary policy announcement on Wednesday but managed to end the day modestly higher. With the upward move, the Dow reached a new record closing high. President Barack Obama sought to emphasize in remarks on Wednesday that the American forces being deployed as part of the fight against the terrorist group ISIS will not have a combat mission. Republican Joni Ernst has moved into the lead in the potentially crucial Iowa Senate race, according to the results of a Quinnipiac University poll released on Wednesday. The poll found that 50 percent of likely Iowa voters would support Ernst if the election were held today, while 44 percent would vote for Democratic Rep. Bruce Braley.
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.