The FDA today voted to expand the approved use of rivaroxaban (Xarelto, Janssen Pharmaceuticals) to include the treatment of deep vein thrombosis or pulmonary embolism.
“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,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the release.
The FDA approved the expanded use under its priority review program, which allows for an expedited 6-month review for drugs that offer major advances in treatment or offer a treatment where none exist.
The approval comes after encouraging results from the three EINSTEIN studies, which involved more than 9,000 patients with thromboembolic events.
In July 2011, the FDA approved rivaroxaban to reduce the risk of DVT and PE after knee or hip replacement surgery. In November 2011, the agency approved the drug to reduce stroke risk individuals with non-valvular atrial fibrillation.
thanks HemOnc Today
“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,” Richard Pazdur, MD, director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research, said in the release.
The FDA approved the expanded use under its priority review program, which allows for an expedited 6-month review for drugs that offer major advances in treatment or offer a treatment where none exist.
The approval comes after encouraging results from the three EINSTEIN studies, which involved more than 9,000 patients with thromboembolic events.
In July 2011, the FDA approved rivaroxaban to reduce the risk of DVT and PE after knee or hip replacement surgery. In November 2011, the agency approved the drug to reduce stroke risk individuals with non-valvular atrial fibrillation.
thanks HemOnc Today
