Keywords: Bayer, Xarelto, Visanne, VTE, Endometriosis, FDA, Europe, USA

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

Article | 7 December 2009

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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.

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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.

The Phase III EINSTEIN-Extension data showed that, among patients who had been treated for a previous deep vein thrombosis (DVT) or pulmonary embolism (PE), the rivaroxaban group showed a highly statistically-significant relative risk reduction of 82% in the recurrence of a symptomatic VTE versus those treated with placebo (1.3% vs 7.1%, respectively; p

<0.0001). rates of major bleeding, the primary safety endpoint, were low and not statistically significantly different between the two groups (0.7% vs 0.0%; p="0.11).">

Shares in Bayer fell 1.4% when trading opened this morning, making it one of the top decliners among German large-caps, according to a Reuters report.

Visanne cleared for endometriosis

Meantime, the German group’s Bayer Schering Pharma unit has successfully completed the decentralized part of drug approval procedure in Europe for a new treatment of endometriosis for Visanne, a once-daily oral tablet containing dienogest 2mg that has been developed specifically for the treatment of endometriosis. A dedicated clinical study program has proven that Visanne relieves endometriosis pain with high efficacy, reduces endometriosis lesions and demonstrates a favourable safety and tolerability profile. Market launch of the product is planned from the second quarter 2010 onwards, the firm stated.

“With Visanne, we will be able to offer women a new treatment option which can reduce the substantial burden of endometriosis,” said Phil Smits, head of Bayer Schering Pharma’s Business Unit Women’s Healthcare. “Surgical treatment of endometrosis is associated with high relapse rates and many currently available medical therapy options have side effects which do not allow for long-term use. Patients often need to use different combinations of the available treatment options and even undergo repeat surgical procedures. There is therefore a high medical need for new treatment options,” he noted.