Edoxaban gets its turn before FDA panel

An FDA advisory committee is scheduled to review an application for another novel oral anticoagulant to reduce the risk of stroke or systemic embolism in patients with nonvalvular atrial fibrillation.

The Cardiovascular and Renal Drugs Advisory Committee will assess the safety and efficacy of edoxaban (Lixiana, Daiichi Sankyo), a Factor Xa inhibitor, at its Oct. 30 meeting.

To date, three novel anticoagulants have been cleared for use in the U.S.: dabigatran (Pradaxa, Boehringer Ingelheim), a direct thrombin inhibitor; rivaroxaban (Xarelto, Janssen Pharmaceuticals/Bayer HealthCare), a Factor Xa inhibitor; and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer) also a Factor Xa inhibitor.

In the ENGAGE AF-TIMI 48 (Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48) trial, both low-dose and high-dose edoxaban were shown to be noninferior to warfarin for the prevention of stroke or systemic embolism. The annualized stroke rates were 1.5 percent for warfarin, 1.18 percent for high-dose edoxaban and 1.61 percent for low-dose edoxaban.

Both doses also demonstrated lower rates of major bleeding and death from cardiovascular causes compared with warfarin. The annualized rate of major bleeding was 3.43 percent with warfarin, 2.75 percent with high-dose edoxaban and 1.61 percent with low-dose edoxaban. Cardiovascular death rates were 3.17 percent for warfarin, 2.74 percent for high-dose edoxaban and 2.71 percent for low-dose edoxaban.