logo
Share SHARE
FONT-SIZE Plus   Neg

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.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Computer and printer maker Hewlett-Packard Co. said Thursday after the markets closed that its second quarter profit fell 21% from last year, hurt by lower revenue and costs related to the planned separation of the company. However, the company's quarterly earnings per share, excluding items, came in above analysts' expectations, but its quarterly revenue fell short of analysts' forecast. Accounting software maker Intuit reported a plunge in third-quarter profit, hurt by impairment charges, even as results topped Wall Street estimates, driven by growth in small business segment amid a strong tax season. Struggling teen-apparel retailer Aeropostale Inc. (ARO), Thursday said its first-quarter loss narrowed from a year ago, driven largely by stronger margins even as revenues continued to plunge dropped. Nevertheless, the company lost almost one-fifth of its market value in after-hours trade, with the...
comments powered by Disqus
Follow RTT