FDA expands Bayer/Janssen's Xarelto use to treat, reduce recurrence of blood clots

The US Food and Drug Administration (FDA) late Friday approved German drug major Bayer’s (BAYN: DE) oral anticoagulant Xarelto (rivaroxaban) for the treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), ie, leg and lung blood clots, and to reduce the risk of recurrent DVT and PE.

The drug is still awaiting an agency decision on its use in combination with standard antiplatelet therapy to reduce the risk of secondary cardiovascular events in patients with Acute Coronary Syndrome (ACS). In this respect, the FDA issued a competed response letter on the supplemental New Drug Application for Xarelto, citing missing clinical trial information made it difficult to interpret the data (The Pharma Letter June 22), to which US marketing partner Janssen Pharmaceuticals, a unit of US health care giant Johnson & Johnson (NYSE: JNJ) responded to in September.

New indication could add $600 million to revenues