Bayer and Johnson & Johnson's Xarelto (rivaroxaban) was shown to be as effective as the standard combination therapy of sanofi-aventis' Lovenox (enoxaparin) and warfarin in preventing deep vein thrombosis in a Phase III trial, Bayer announced Wednesday. "The results of this study confirm that the novel, convenient single drug treatment approach with rivaroxaban could replace the current standard therapy in the treatment of patients suffering from deep vein thrombosis," noted Bayer Healthcare CMO Kemal Malik.
Data from the EINSTEIN-DVT trial, which enrolled more than 3400 patients, demonstrated that patients treated with Xarelto had a similar rate of fatal or non-fatal symptomatic recurrent VTE as those treated with standard therapy. In addition, Xarelto's rate for the composite of major and clinically relevant non-major bleeding, the primary safety outcome of the study, was similar to the Lovenox combination. Bayer noted that full data from the study will be presented later this month at the meeting of the European Society of Cardiology.
Bayer is currently conducting a study of the drug in patients with atrial fibrillation, and data is expected later this year. The drugmaker said it plans to apply for regulatory approval for the drug in both DVT and atrial fibrillation by the end of the year, but Barclays Capital analysts suggest that the drugmaker may have difficulty proving that Xarelto is as effective as Boehringer Ingelheim's Pradaxa (dabigatran) in preventing strokes in this patient cohort. The analysts noted that if the drug fails commercially in patients with atrial fibrillation, it could result in Xarelto achieving revenues of 340 million euros ($447 million) in 2015. Bayer has previously suggested that Xarelto could eventually generate annual sales of more than 2 billion euros.
Xarelto is currently approved in Europe for the prevention of thrombosis in patients following orthopaedic sugery. The FDA in May 2009 declined approval of the drug for this indication. Bayer and Johnson & Johnson have previously said that they would need until the second-half of 2010 to respond to the agency's request for additional information related to their marketing application.
To read more Top Story articles, click here.