An FDA advisory panel voted 9-1 in favor of approval of the anticoagulant edoxaban to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation.
The Cardiovascular and Renal Drugs Advisory Committee reviewed the safety and efficacy results from the ENGAGE-AF-TIMI 48 trial. Findings pointed to a reduced rate of stroke and systemic embolism in nonvalvular atrial fibrillation patients and showed edoxaban as noninferior to warfarin in the prevention of stroke or systemic embolism using both high and low dosage (60 mg and 30 mg).
While the committee approved edoxaban (Savaysa, Daiichi Sanko) for use, voting was divided on whether or not a 60 mg dose should be administered for patients with normal renal function due to some increased risks for bleeding seen in a subanalysis. FDA representative Ellis Unger, MD, said of the dosage issue, “The people prescribing this are pretty sophisticated physicians. (Adjusting doses) is doable.”
Edoxaban is a Factor Xa inhibitor. The FDA already gave a green light to two other Factor Xa inhibitors, rivaroxaban (Xarelto, Janssen Pharmaceuticals/Bayer HealthCare) and apixaban (Eliquis, Bristol-Myers Squibb/Pfizer), for this indication. The thrombin-inhibitor dabigatran (Pradaxa, Boehringer Ingelheim) also is marketed in the U.S.
The FDA often but not always follows the recommendations of its advisory committees.