FDA fast-tracks Xarelto for PE, DVT

The FDA has assigned a priority review designation to the supplemental New Drug Applications for rivaroxaban (Xarelto), an oral anticoagulant seeking new indications to treat patients with deep vein thrombosis (DVT), pulmonary embolism (PE) and to prevent their recurrence, Janssen Research & Development announced July 9.

In a separate move, Janssen R&D said it is withdrawing the sNDA for the use of rivaroxaban to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS). On June 24, the FDA sent a complete response letter to the company for its sNDA for the reduction of the risk of secondary cardiovascular events in patients with ACS.

Janssen R&D filed the sNDA for on DVT and PE May 2. FDA is expected to complete its review within six months from the receipt of the sNDA submission.

“Our top priority is to work with FDA on our original sNDA for ACS and submit our reply to the complete response letter as soon as possible,” Paul Burton, MD, PhD, vice president, cardiovascular franchise medical leader at Janssen R&D, said in a release. “We plan to resubmit the sNDA for stent thrombosis at the same time.”

Reviewers may look at data from the EINSTEIN program, which includes two Phase 3 studies evaluating the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE and the prevention of recurrent events in these patients, according to Janssen R&D. A third Phase 3 study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent DVT and PE.