Bayer says US filing for Xarelto delayed; Visanne cleared in Europe

German drug major Bayer announced over the weekend details of data from the EINSTEIN Extension study for Xarelto (rivaroxaban), under development with US health care giant Johnson & Johnson,  due to be presented at the American Society of Hematology in New Orleans conference on December 8.

There is limited new information on the EINSTEN study versus that previously seen in the abstract but there is an update on the US Food and Drug Administration regulatory status. Xarelto has filed at the FDA for VTE prevention after surgery and received a complete response letter from the agency in May 2009. Bayer/J&J are in discussions with the FDA and are required to submit data from completed and ongoing studies post-marketing surveillance (ex-USA) and information on the RECORD study sites.

The companies had previously guided to an FDA re-filing by end 2009. In the press release, they have announced that re-filing is delayed so that FDA 'requirements are fully addressed.' Bayer reiterated that no new clinical or non-clinical studies are required and the company said it will update on re-filing strategy at its 2009 financial results in February next year.