Johnson & Johnson’s blood clot preventer Xarelto has come out well in clinical trials, with results comparable to other treatments for blood clotting in the lungs. A study of nearly 5000 patients showed effectiveness and safety were on par with anything else on the market, meaning the drug is poised to move forwards and possibly become a front-runner for hospitals around the world.

The generally accepted treatment used, a combination injection of heparin and warfarin in pill form, was compared with Xarelto. Clots can often form in the legs and then break loose and become lodged in the lungs. In what was the largest clinical trial to date for lung clot treatment, those on Xarelto also known by its chemical name rivaroxaban, experienced only half the number of major bleeding incidents, mainly brain hemorrhages.

Dr. Harry Buller, a professor of vascular medicine at the Academic Medical Center in Amsterdam, who led the trial, presented the results on Monday at the annual scientific sessions of the American College of Cardiology in Chicago. He said:

“Rivaroxaban is just as good as standard treatment for pulmonary embolism — these data are pretty convincing — and this is an oral-only approach, which makes it very simple.”

Buller continued that the J&J sponsored trial showed :

  • 10.3 percent of patients taking Xarelto had major or minor bleeding.
  • 11.4 percent of those taking heparin and warfarin.
  • 1.1 percent of patients taking Xarelto experienced major bleeding.
  • 2.2 percent on standard dual therapy had major bleeding.

Paul Burton, cardiovascular medical leader at J&J’s Janssen division, said in an interview :

“Xarelto has the potential to become the new standard of care. It may offer the opportunity for a single drug that doesn’t require monitoring to be used in acute and long-term treatment of pulmonary embolism.”

It might not sound like much until you consider that blood clots kill some 600,000 Americans each year, and not only that, its big business, with analysts at Morningstar, estimating that Xarelto could add some $500 million in annual revenue to J&Js bottom line.

Xarelto has been developed by J&J in partnership with the German company Bayer AG. It is already approved for use against blood clotting in the legs and lungs for patients who have undergone hip replacements or knee surgery. It’s also used to prevent strokes for people with irregular heartbeats. The fact that it’s already in use should pave the way for it to be quickly adopted.

Warfarin, which is also used in rat poison, is a difficult drug to administer, obviously too much leads to patients having uncontrolled hemorrhages. Bristol-Myers Squibb Co and Pfizer Inc have a competing drug on the market known as Eliquis, which works in a similar way by blocking the Factor Xa protein involved in the clotting process, but avoids the need for strict patient monitoring and special diets. Eliquis is not yet approved for lung clots, so Xarelto looks set to become the drug of choice for treating patients.

Written by Rupert Shepherd