Xarelto non-inferior to standard therapy in VTE

Johnson & Johnson (NYSE:JNJ) said oral Xarelto rivaroxaban was non-inferior to standard therapy of enoxaparin followed by a vitamin K antagonist in the Phase III EINSTEIN-PE trial for the treatment and secondary prevention of recurrent symptomatic venous thromboembolism (VTE). Xarelto led to a 2.1% incidence of symptomatic recurrent VTE, the primary endpoint, compared to a 1.8% incidence with standard therapy (p=0.003 for non-inferiority). The open-label trial, conducted by J&J and partner Bayer AG (Xetra:BAYN), enrolled 4,833 patients with acute symptomatic pulmonary embolism (PE) with or without deep vein thrombosis (DVT).

There was no significant difference between treatment groups on the primary safety endpoint of major or clinically relevant non-major bleeding episodes (10.3% vs. 11.4%, p=0.23). Xarelto did significantly reduce the incidence of major bleeding events vs. standard therapy (1.1% vs. 2.2%, p=0.003). Data were presented at the American College of Cardiology meeting in Chicago and published in the New England Journal of Medicine. J&J plans to submit an sNDA to FDA for Xarelto to treat and prevent VTE in patients with PE in 2Q12. ...