US priority review for two Xarelto sNDAs; one dropped

The US Food and Drug Administration has assigned a priority review designation to the supplemental New Drug Applications (sNDAs) filed on May 2 by Johnson & Johnson’s (NYSE: JNJ) Janssen Research & Development subsidiary for (rivaroxaban), an oral anticoagulant for which the firms have US development and commercializing rights from Germany’s Bayer (BAYN: DE), seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE), and to prevent recurrent DVT and PE.

"We are delighted to have received a priority review designation for Xarelto for the treatment of PE and DVT, and also to prevent the recurrence of these conditions. Each year an estimated 900,000 Americans experience a DVT or PE, and one third of those events are fatal. If approved for these indications, Xarelto has the potential to address critical unmet needs in treating patients with these serious medical conditions," said Paul Burton, vice president, cardiovascular franchise medical leader at Janssen R&D.

The FDA grants priority review to medicines that offer major advances in care or provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), FDA will aim to complete its review within six months from the receipt of the sNDA submission, rather than the standard 10 month review cycle.