Innovative oral tablet for blood clot prevention

Innovative oral tablet for blood clot prevention after total hip or knee

replacement surgery funded from 1 December 2010
Bayer’s novel oral anticoagulant Xarelto® funded for use in New Zealand

Auckland, 29 November 2010 – A simple and effective treatment from Bayer HealthCare is to become more available in New Zealand for the prevention of venous thromboembolism (VTEs) in adult patients undergoing major joint replacement surgery. PHARMAC has announced access changes for Xarelto® (rivaroxaban) from 1 December 2010.

Xarelto will be funded for the prevention of venous thromboembolism following elective total hip or knee replacement surgery. Xarelto is an oral, direct Factor Xa inhibitor taken as one tablet once-daily and does not require injection or routine coagulation monitoring.

Bayer HealthCare’s Medical Director for Australia and New Zealand, Dr Jan Twomey, said “access to fully subsidised Xarelto would assist healthcare professionals in the prevention of VTE, and offer patients relief from the inconvenience of injectable therapies.

“VTE is one of the most common serious complications seen in hospitals and after orthopaedic surgery, yet it is one of the most preventable.”

During and after hip or knee replacement procedures, there is a significant increase in the risk of VTE due to various factors such as the surgery itself and the associated decrease in mobility. Nearly 7000 knee replacement and nearly 6000 hip replacement operations are performed in New Zealand each year.

Dr Twomey said Xarelto was also being extensively trialled around the world for other indications, including the prevention and treatment of a wide range of acute and chronic blood-clotting disorders. This included stroke prevention in patients with atrial fibrillation (AF), VTE prevention in hospitalised medically ill patients, and the secondary prevention of acute coronary syndrome.

Xarelto was invented in Bayer’s Wuppertal laboratories in Germany, and jointly developed by Bayer HealthCare and Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Marketing approval for Xarelto in New Zealand was received in August 2009 following a review of data from the extensive RECORD clinical program that included three Phase III trials of Xarelto involving nearly 10,000 patients undergoing elective hip or knee replacement surgery (RECORD 1, 2 and 3 trials). Results from these three studies demonstated the superior efficacy of Xarelto, both in head-to-head comparisons with enoxaparin and with a short duration treatment course of two weeks with enoxaparin. Xarelto and enoxaparin had comparable safety profiles including low rates of major and surgical site bleeding.

ENDS

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