November 3rd, 2012
Rivaroxaban Gains FDA Indications for Treating and Preventing DVT and PE
The FDA has expanded the indication for rivaroxaban (Xarelto, Johnson & Johnson) to include the treatment of deep-vein thrombosis (DVT) and pulmonary embolism (PE) and to reduce the risk for recurrent DVT and PE.
The oral anticoagulant is already approved to reduce postsurgical risk for DVT and PE after hip- and knee-replacement surgery and to reduce the risk for stroke in people with atrial fibrillation. The new indication was granted under the FDA’s priority review program.
“Xarelto is the first oral anti-clotting drug approved to treat and reduce the recurrence of blood clots since the approval of warfarin nearly 60 years ago,” said Richard Pazdur, director of the FDA’s Office of Hematology and Oncology Products, in an FDA press release.