Bayer and J&J initiate new trials to expand use of Xarelto

German drug major Bayer (BAYN: DE) and partner Janssen, a subsidiary of US health care giant Johnson & Johnson (JNJ), have expanding the clinical trial program of what is already the world’s most-studied oral anticoagulant, Xarelto A (rivaroxaban) with the aim of securing additional indications for the drug.

Xarelto, which is already approved and marketed for several indications (the most important being stroke prevention in patients with atrial fibrillation), generated sales of 322 million euros ($418 million) in 2012, and Bayer has forecast peak sales of 2 billion euros for the drug. However, there was a setback earlier this month, when the US Food and Drug Administration  issued a second complete response letter regarding its supplemental New Drug Administration (sNDA) for Xarelto for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome (The Pharma Letter March 5).

The companies are initiating five new global clinical trials, including studies in patients with chronic heart failure patients and another in patients with coronary artery disease or peripheral artery disease. Also, of considerable interest among the clinical community is a study in patients who have non-valvular atrial fibrillation and are undergoing percutaneous coronary intervention (PCI) with stent placement. The trial will assess Xarelto in combination with dual antiplatelet therapy and when aspirin is not used.