Daiichi Sankyo has announced submission of a New Drug Application to the FDA for edoxaban, its investigational direct factor Xa inhibitor, according to a press release.
The company will seek approval for the once-daily oral drug for the treatment of pulmonary embolism and deep vein thrombosis, as preventive treatment for recurrent symptomatic venous thromboembolism, and for the reduction of risk for stroke and systemic embolic events among patients with nonvalvular atrial fibrillation.
Edoxaban is currently approved in Japan for the prevention of VTE after orthopedic surgery. If approved in the United States, the drug would be marketed by Daiichi Sankyo under the brand name Savaysa.
The submission follows results from two phase 3 trials comparing edoxaban with warfarin in patients with AF or VTE: ENGAGE AF-TIMI 48, which assessed the drug in 21,105 patients, and Hokusai-VTE, which assessed the drug in 8,292 patients.
“If approved, edoxaban may provide a new treatment option for physicians and their patients with these diseases,” Glenn Gormley, MD, PhD, senior executive officer and global head of research and development for Daiichi Sankyo, stated in the release. “We look forward to working with the FDA as it conducts its review of edoxaban.”
In a separate press release, the company also announced that it has submitted a Marketing Authorization Application to the European Medicines Agency for edoxaban, with the same proposed indications.