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Study: Xarelto safer than current pulmonary embolism therapies

Boost for J&J and Bayer ahead of regulatory filings in US and Europe

A new study of Johnson & Johnson/Bayer's oral anticoagulant Xarelto in patients with pulmonary embolism (PE) has shown that it is as effective as standard therapy regimens but is associated with significantly fewer major bleeding episodes.

The 4,833-patient EINSTEIN PE trial was presented yesterday at the American College of Cardiology annual meeting in Chicago and showed that Xarelto (rivaroxaban) was as good as low-molecular weight heparin (LMWH) followed by warfarin in preventing PE patients from developing a secondary venous thromboembolism.

Moreover, it cut the risk of major bleeds such as intracranial haemorrhage by 50 per cent, and was especially effective in reducing risk in elderly patients.

The trial was not intended to show superiority to the LMWH-based regimen, rather to show equivalence, but EINSTEIN PE is the first to make a direct comparison between a new anticoagulant and LMWH from the outset.

Most other studies have treated all patients with LMWH in the initial treatment phase, and made a comparison with warfarin in the maintenance phase, so showing equivalence and improved safety is a home run for J&J and Bayer.

Furthermore, Xarelto is a much simpler regimen for cardiologists to administer to their patients, mainly because it avoids the need for injections and routine blood monitoring with current standard therapy.

In EINSTEIN PE, patients on Xarelto received 15mg twice-daily for three weeks, followed by 20mg once daily for the remainder of the study.

J&J and Bayer say they now plan to file Xarelto for approval in PE in the US and Europe in the second quarter of this year. The drug is already approved for preventing strokes in patients with atrial fibrillation and blood clots in patients undergoing hip or knee replacement surgery.

If approved, the PE indication could add upwards of $1bn to Xarelto's peak sales potential, according to analysts.

The results of the idea were simultaneously published online on the New England Journal of Medicine website.

27th March 2012

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