FDA Panel Backs Daiichi Sankyo, Inc.'s New A-Fib Drug Savaysa

FDA Panel Backs Daiichi Sankyo's New A-Fib Drug Savaysa

October 31, 2014

By Riley McDermid, BioSpace.com Breaking News Staff

Japanese drugmaker Daiichi Sankyo Company said Friday that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to approve its new stroke drug Savaysa in patients with non-valvular atrial fibrillation.

Daiichi Sankyo has had high hopes for once-a-day Savaysa (edoxaban), which uses 60 mg dosing regimen to reduce the risk of stroke and systemic embolic events. The FDA panel made its recommendation after it was provided with data from an ENGAGE AF-TIMI 48 study results, which was previously presented at the 2013 American Heart Association Scientific Sessions.

The global edoxaban clinical trial program includes two Phase III clinical studies, Hokusai-VTE and ENGAGE AF-TIMI 48, which included nearly 30,000 patients combined.

The latter found that Savaysa is comparable to popular drug warfarin in reducing the risk of stroke and SEE in patients with NVAF, and demonstrated “significantly less” major bleeding compared to warfarin. Members of the FDA panel agreed with the drug’s efficacy and will recommend it for final 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, senior executive officer and global head of research and development at Daiichi Sankyo. "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 will now focus on winning approval from the FDA for the 60 mg dosing regimen of edoxaban for the reduction in risk of stroke and SEE in patients with NVAF. It will provide a dose reduction to 30 mg for patients with known risk factors such as renal impairment, low body weight or concomitant use of certain P-glycoprotein inhibitors.

It would also like edoxaban approved for the treatment and prevention of recurrence of symptomatic venous thromboembolism (VTE) and hoped it can get a green-light for that application on the strength of its data from the Hokusai-VTE study, which is the single largest comparative trial of a novel oral anticoagulant in this patient population.

Atrial fibrillation (AF) causes a rapid and irregular heartbeat that can sometimes lead to stroke. It affects 2.3 to 3.4 percent of people in developed nations, with approximately 6.1 million people in the U.S. suffering from it. Stroke is the second most common cause of death worldwide, responsible for approximately 6.2 million deaths each year, said the company, and people with the arrhythmia have a 3 to 5 times higher risk of stroke.

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