FRANKFURT, Dec 8 (Reuters) - Experimental drug rivaroxaban works better than the standard treatment with enoxaparin to prevent blood clots in patients following hip replacement surgery, a late stage study has shown.
Bayer BAYG.DE and Johnson & Johnson (JNJ.N), which jointly develop the experimental blood-thinner drug, were to release the data at the American Society of Hematology in Atlanta.
According to the RECORD 1 study, rivaroxaban reduced the incidence of all types of venous thromboembolism (VTE) or blood clot risk 70 percent more than Sanofi-Aventis’ (SASY.PA) enoxaparin group. For major VTE risk, the figure was 88 percent.
Enoxaparin is also known by its marketing name as Lovenox.
The study showed the risk of major and non-major bleeding was similar for both drugs.
The head-to-head study involving 4,541 patients was led by orthopedic surgeon, Bengt Eriksson, of the Sweden Sahlgrenska University Hospital.
Some of the patients were given 10 mg rivaroxaban once a day about 6-8 hours after a surgery, while others got a once-daily injection of 40 mg enoxaparin, which was started the evening before surgery. Both treatments continued for 5 weeks.
Bayer and Johnson & Johnson will release trials from other rivaroxaban studies on Monday at the hematology meeting.
Rivaroxaban, which Bayer wants to market under the trade name Xarelto, is the most promising product in its pipeline.
Rivaroxaban’s current indications are for prevention of VTE, treatment of deep-vein thrombosis, stroke prevention in atrial fibrillation and acute coronary syndrome.
Last month, Bayer said it was also planning a late-stage study for hospitalised patients with internal diseases.
Bayer has already submitted the first registration applications in Europe to market rivaroxaban for prevention of VTE following major orthopedic surgery.
Bayer expected annual peak sales potential of rivaroxaban to exceed 2 billion euros ($2.91 billion). (Reporting by Mantik Kusjanto; Editing by Matthew Tostevin)