A panel of cardiology experts of the Food and Drug Administration voted 15 to 2 on Thursday in favor of anticlotting drug rivaroxaban, which if approved, would be the first new pill-based anticlotting drug in a half-century.

 

Rivaroxaban, also known as Xarelto, proved more effective at reducing potentially fatal blood clots than heparin, a widely used blood thinner, with no increase in side effects, according to three research teams that published their papers in June edition of the New England Journal of Medicine and The Lancet.

 

Rivaroxaban is a joint venture between Bayer Healthcare Pharmaceuticals and Johnson & Johnson, which have applied to the FDA for approval to market the drug for short-term use in preventing deep-vein thrombosis and pulmonary embolism in patients undergoing total hip or knee replacement surgery.

 

Although the drug proved generally effective in reducing blood clots, it still had side effects. To be more specific, 24 study patients taking rivaroxaban subsequently had major bleeding – the kind that can require surgical intervention – compared with 13 who had injections.

 

Also, the drug was associated with liver damage, but “the much-hyped liver safety concern was put to bed by a very clear evaluation of the patients in question,” Deutsche Bank analysts Michael Leuchten and Tim Jones wrote in a note to investors.

 

The drug is already sold in Europe by Johnson & Johnson. The FDA is expected to make a decision on the drug by May 28. If approved, Bayer would receive a royalty as high as 30 percent on US sales, under an agreement with J&J.