Atrial Fibrillation Drug Approval Endorsed by FDA Committee

October 31, 2014
Katie Eder, Senior Editor

The FDA's Cardiovascular and Renal Drugs Advisory Committee has recommended the approval of edoxaban (Savaysa) for treating patients with nonvalvular atrial fibrillation, a type of arrhythmia that can potentially cause a stroke.

The FDA’s Cardiovascular and Renal Drugs Advisory Committee has recommended the approval of edoxaban (Savaysa) for treating patients with nonvalvular atrial fibrillation (NVAF), a type of arrhythmia that can potentially cause a stroke.

According to Savaysa manufacturer Daiichi Sankyo, the once-daily anticoagulant demonstrated non-inferiority to warfarin in reducing the risk of stroke and systemic embolic events (SEE) among patients with NVAF and showed significantly less major bleeding compared with warfarin in the late-stage ENGAGE AF-TIMI 48 trial. Based on that trial data, the FDA committee voted 9 to 1 to recommend the drug’s approval.

“We are confident that the outcomes and robustness of the ENGAGE AF-TIMI 48 study fully support the approval in the U.S. of the 60 mg dosing regimen of Savaysa for patients with NVAF, with a dose reduction to 30 mg in selected patients,” said Glenn Gormley, MD, PhD, senior executive officer and global head of research and development for Daiichi Sankyo Co Ltd, and executive chairman and president for Daiichi Sankyo, Inc. “We will continue to work with the FDA as it completes its review of our new drug application for Savaysa for the prevention of stroke and SEE in patients with atrial fibrillation.”

Daiichi Sankyo is currently seeking approval from the FDA for the 60 mg dosing regimen of edoxaban, with a dose reduction to 30 mg in patients with known renal impairment, low body weight, or concomitant use of certain P-glycoprotein inhibitors that can potentially increase the risk of bleeding due to higher edoxaban exposure. The manufacturer is also seeking FDA approval of edoxaban for the treatment and prevention of recurrence of symptomatic venous thromboembolism.

The FDA regularly seeks the advice of its advisory committees, but it is not bound to follow their recommendations.