J&J's Janssen files Xarelto with FDA for new indication; buys Chinese firm

US health care major Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Research & Development says it has submitted a supplemental New Drug Applications to the US Food and Drug Administration seeking approval for the use of Xarelto (rivaroxaban), an oral anticoagulant, to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention of recurrent venous thromboembolism (VTE).

Xarelto, partnered with Germany’s Bayer (BAYN: DE) which sells the drug outside the USA, was approved by the FDA in July 2011 for the prevention of VTE in adults following elective hip or knee replacement surgery. Last month, Bayer filed with the European Medicines Agency seeking approval of Xarelto for the treatment of PE and the prevention of recurrent DVT and PE in adults (The Pharma Letter April 12). The drug has been touted as by Bayer as having a peak sales potential of around 2 billion euros ($2.65 billion) outside the USA.

Filing backed by data from EINSTEIN program