FDA approves Xarelto to Prevent Stroke
The FDA has approved rivaroxaban (Xarelto ®) for prevention of stroke in patients with non-valvular atrial fibrillation, making it the first oral direct Factor Xa inhibitor to be approved for stroke prevention.
Rivaroxaban, an oral direct Factor Xa inhibitor, had already been approved for the prevention of deep vein thrombosis in patients undergoing joint replacement surgery.
The approval was based on findings ROCKET-AF study, which showed that rivaroxaban was as effective as warfarin in preventing stroke and systemic embolism in patients with non-valvular atrial fibrillation. Rivaroxaban was associated with a similar rate of major bleeding, but a lower rate of intracranial hemorrhage.
However, one of the three FDA reviewers, who covered the trial data found that the pharmaceutical company Johnson & Johnson failed to prove that the drug is as effective as warfarin because of suboptimal management of warfarin in the trial . The reviewer recommended against approval of the documents prepared for cardiovascular and renal drugs the FDA Advisory Committee meeting in September.
However, the committee - by a vote of 9-2, with one abstention - recommended approval of the indication of stroke prevention.
Rivaroxaban has already been approved by the FDA in July for the prevention of deep vein thrombosis in patients undergoing knee or hip. That property was based on EINSTEIN DVT study, which showed that rivaroxaban was noninferior to enoxaparin plus warfarin in preventing recurrent deep venous thrombosis.
Rivaroxaban becomes the second in a wave of new anticoagulants to improve the success of warfarin in preventing stroke in patients with atrial fibrillation to be approved by the FDA. Last year, dabigatran (Pradaxa), a direct thrombin inhibitor, was approved.
Other oral direct factor Xa inhibitor in development for stroke prevention in atrial fibrillation, including apixaban, which was recently shown to be superior to warfarin in the opinion of Aristotle, and edoxaban, which is currently being evaluated in ENGAGE trial.
FDA approves Xarelto to Prevent Stroke
