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Bayer's 'revolutionary' anticoagulant Xarelto launched

Published on 04/11/08 at 12:58pm

Xarelto, the new anticoagulant treatment from Bayer has been launched in the UK, and is set to be among a group of new drugs which will revolutionise the therapy area.

The drug is a major launch for Bayer, which predicts that Xarelto (rivaroxaban) could reach blockbuster status, with peak sales of more than 2 billion euros ($2.8 billion) and could one day be used to prevent strokes and a variety of blood clot-related conditions.

But the drug faces competition from a recently launched rival, Boehringer Ingelheim's Pradaxa, which has already secured NICE recommendation in the UK.

Both companies claim their drugs will be 'revolutionary' in treating blood clots, but this process will not happen overnight, as the area is frequently overlooked at present.

First indication

Xarelto's first licensed indication is to prevent venous blood clots in patients undergoing elective hip or knee replacement surgery, one of the most common causes of potentially fatal blood clots.

There are 160,000 hip and knee replacement operations every year in the UK, and due to the invasive nature of the procedure and the lack of mobility it causes in patients, nearly half would develop a blood clot if no preventative treatment were given.

Sanofi-Aventis' Clexane is the current mainstay of treatment, and is injected for at least six days after an operation until the patient starts walking again. But its injectable formulation makes it inconvenient when longer term treatment is required.

Moreover, Bayer says its clinical trials show Xarelto to be significantly more effective than Clexane in preventing blood clots, potentially helping to prevent many unnecessary deaths.

Bayer and its rival in the market Boehringer Ingelheim are both conscious of the current low-level of awareness about the number of deaths from blood clots every year.

The companies and patient groups say limitations of commonly used treatments and lack of compulsory patient risk assessment mean that many patients are still being put at risk by not receiving preventative treatment.

Beverley Hunt, medical director of Lifeblood: The Thrombosis Charity, comments: "Despite the clear evidence of benefit and the existence of national guidelines, current provision of thromboprophylaxis for hospitalised patients is suboptimal, and hospital-acquired DVTs continue to cause unnecessary suffering and death.

"As a health professional and campaigner for improved patient care, I hope the introduction of new, effective and convenient anticoagulants such as Xarelto will mean more patients, especially those in high risk groups, will benefit in the future."

The cost to the NHS of treating patients who develop hospital-acquired blood clots from all causes is thought to be as high as £222.8 million per year, much higher than the cost of treating MRSA (£45 million), an area singled out as a priority by the government.

Professor Ajay Kakkar is professor of surgical sciences, Barts and the London School of Medicine and Dentistry and director of the Thrombosis Research Institute in London. He comments: "Thrombosis remains a major clinical challenge and today's announcement of the availability of Xarelto provides exciting new opportunities to protect patients from potentially fatal blood clots."

Nearly 50,000 patients around the world will be recruited into Xarelto's extensive development programme, which will study the drug in a broad range of acute and chronic blood-clotting disorders including VTE treatment, stroke prevention in patients with atrial fibrillation, VTE prevention in hospitalised patients, and secondary prevention of acute coronary syndrome.

NICE has already begun its appraisal of Xarelto, and is expected to publish its guidance in June 2009.

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