Please login to the form below

Not currently logged in
Email:
Password:

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

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
bmore group

OUR PROMISE: BETTER HEALTH FROM TRIAL TO TREATMENT.We are a full service, independent network of specialist agencies under one roof....

Latest intelligence

OUTiCO win Best in UK Pharmaceutical Outsourcing award
The Corporate LiveWire Healthcare and Life Sciences Awards celebrate global companies and individuals who have excelled over the past 12 months....
artificial-intelligence-in-healthcare.jpg
Artificial Intelligence in Healthcare
Artificial intelligence is already out-diagnosing experts, but would you put a computer in charge of your healthcare? The good, the bad; we take a look....
World Pancreatic Cancer Day 2018: Combating misconceptions in pancreatic cancer
Patients diagnosed with pancreatic cancer face a dismal prognosis, with the disease having the lowest survival rate of all major cancers. In spite of this, pancreatic cancer research is chronically...

Infographics