Pharmaceutical Business review

FDA approves Janssen once-daily anti coagulant

Xarelto, an once-daily oral dosing anticoagulant, works by blocking the Xa blood clotting factor.

The approval of Xarelto is backed by the pivotal double-blind Phase 3 ROCKET AF (Rivaroxaban Once-daily oral direct Factor Xa inhibition Compared with vitamin K antagonism for the prevention of stroke and Embolism Trial in Atrial Fibrillation) global clinical trial.

The trial demonstrated that a once-daily rivaroxaban reduced the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, with major bleeding rates comparable to warfarin.