US FDA approves Bayer and J&J's Xarelto to help prevent DVT following hip/knee replacement surgery

German drug major Bayer (BAY: DE) and US marketing partner Janssen Pharmaceuticals, a unit of Johnson & Johnson (NYSE: JNJ) says that the US Food and Drug Administration has approved their Xarelto (rivaroxaban), a novel, once-daily, oral anticoagulant for the prevention of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery, an indication it already has in Europe.

This is the first step into the DVT prevention market, which is forecast to reach a value of around $15 billion. The companies are aiming for a wider indication for the drug in the larger market for patients with an irregular heartbeat (atrial fibrillation) that can lead to stroke. The FDA will probably decide on the drug’s use for the bigger patient group by the end of 2011, Martin Fitchet, head of J&J’s cardiovascular research, said at a May 26 conference with analysts, reported the Bloomberg news service.

Will compete with Pradaxa and Eliquis