Bayer and J&J's Xarelto gets US Priority Review for new indication

The US Food and Drug Administration has granted Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for the oral anticoagulant Xarelto (rivaroxaban) in combination with standard antiplatelet therapy to reduce the risk of (thrombotic) cardiovascular events in patients with Acute Coronary Syndrome (ACS).

The drug is being developed by Germany’s Bayer (BAY: DE), together with its cooperation partner, Janssen Research & Development, a Johnson & Johnson (NYSE: JNJ) subsidiary, which will market the product in the USA and pay royalties, which could be as much as 30% to Bayer, the German company’s Jorg Reinhardt, chief executive of Bayer Healthcare told The Pharma Letter at its annual results press conference in Leverkusen yesterday (see separate story today).

The FDA grants Priority Review to medicines that offer advances in care or that provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), FDA will complete its review within six months from the receipt of the sNDA submission. Rivaroxaban is marketed under the brand name Xarelto for VTE prevention in adult patients following elective hip or knee replacement surgery. The drug is approved in more than 110 countries worldwide and marketed outside the USA by Bayer HealthCare in this indication.