FDA
6th November 2014

FDA Panel Votes in Favor of Edoxaban Approval

Last week, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9 to 1 in favor of approving edoxaban (Daiichi-Sankyo) for the prevention of stroke and non–central-nervous-system (CNS) systemic embolism in patients with nonvalvular atrial fibrillation (AF).

FDA Panel Votes in Favor of Edoxaban Approval

Last week, the Cardiovascular and Renal Drugs Advisory Committee (CRDAC) voted 9 to 1 in favor of approving edoxaban (Daiichi-Sankyo) for the prevention of stroke and non–central-nervous-system (CNS) systemic embolism in patients with nonvalvular atrial fibrillation (AF). Edoxaban is a novel anticoagulant that acts as a direct factor Xa inhibitor.

The pivotal study discussed during this meeting was the Effective Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation—Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial; a large study involving 21,105 patients with nonvalvular AF. In the study, once-daily edoxaban was administered at two different dose levels (60 mg and 30 mg). Results showed that edoxaban was noninferior to warfarin, a vitamin-K antagonist, for preventing stroke or systemic embolism in nonvalvular AF patients. Both edoxaban dosages were associated with significantly less major bleeding than warafin.

Questions arose when a subgroup analysis, ENGAGE AF, showed that patients with a creatinine clearance >80 mL/min did not fare as well on treatment as those with abnormal renal function.

In patients with renal impairment, stroke reduction (and thus higher circulating levels of the drug) was highly significant while a trend toward harmful effects appeared in patients with normal renal function.

Panel member Sanjay Kaul, MD, Professor and Cardiologist at UCLA School of Medicine stated that, “The committee struggled with the core issue for discussion around the subgroup of patients with normal renal function where the benefit-risk balance was not optimal…Given the size of the subset, the FDA was concerned about the potential public health impact of approving the drug in patients with normal renal function.”

In general, the Agency does not place a lot of weight on a subgroup analyses, but both FDA reviewers and panel members felt that this discovery could have important clinical implications.

Edoxaban is also being reviewed by the FDA for the treatment of symptomatic venous thromboembolism (VTE) in patients with deep vein thrombosis and/or pulmonary embolism.

ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA AdComs per year than even the largest pharmaceutical companies. For more information on how ISS can help you prepare for your next meeting, contact info@innovativescience.net.

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