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Bayer Schering blood clotting drug a 'major leap forward'

Published on 14/12/07 at 01:38pm

Bayer Schering says its new blood clotting drug Xarelto is poised to set a new standard of care for post-surgery venous thrombembolism, an area of unmet medical need.

The drug is a potential blockbuster and in late-stage trials showed superior efficacy over the standard care of Sanofi-Aventis' Clexane (enoxaparin) and a similar rate of bleeding in patients having total hip or knee replacement surgery.

The company is placing a high premium on Xarelto's (rivaroxaban) safety, which is backed by its biggest ever set of trials, including nearly 10,000 patients in its RECORD programme.

Dr A.G.G. Turpie, principal investigator in the RECORD programme and professor of medicine at Canada's McMaster University, said: "In RECORD1, 2 and 3, we have three phase III trials showing unprecedented results in major orthopaedic surgery for the prevention of venous thrombembolism (VTE) and this is genuinely exciting.

"In three different trials across large patient populations, we have seen rivaroxaban outperform the current standard of care, enoxaparin, without compromising on safety. This is strong clinical evidence that we are making a major leap forward in oral anticoagulation." 

A key secondary endpoint of the study measured the reduction of symptomatic VTE, and here the drug also showed clinically meaningful results that were 'extraordinary', according to Dr Turpie.

Drug safety is a key issue in the therapy area after the 2006 withdrawal of AstraZeneca's Exanta, another VTE treatment and potential blockbuster, due to concerns over its liver side effects.

Bayer Schering said its drug has been extensively studied and, based on clinical evidence to date, there is "no evidence of liver signal attributable to Xaralto".

Head of global development Dr Kemal Malik said: "Bayer Schering Pharma is extremely encouraged by the positive results of the RECORD program which show the potential for rivaroxaban to set a new standard of care in this underserved patient population."

Venous thromboemolism (VTE) is the most frequent complication following major orthopaedic surgery and potentially fatal.

VTE begins with a blood clot in a vein and includes both deep vein thrombosis (DVT) and pulmonary embolism. Patients undergoing major orthopaedic surgery are at high risk for VTE because during orthopaedic surgery the large veins of the leg that carry blood back to the heart are damaged, significantly increasing the risk of coagulation and thrombosis.

Xaralto is being jointly developed by Bayer and Johnson & Johnson and was submitted for European approval by Bayer in October as a treatment for the prevention of VTE in patients undergoing major orthopaedic surgery of the lower limbs.

Xaralto is expected to be filed with the FDA in a similar indication next year and if approved it would be marketed by Scio and Ortho-McNeil, both subsidiaries of Johnson & Johnson.

The drug is due to be launched in Europe next year and has been hailed by the Bayer Schering as one of two key products for its future growth along with its kidney cancer drug Nexavar.

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