Moving Fast: 4th Big New Oral Anticoagulant (Edoxaban, Savaysa) Applies For FDA Approval

Stephan Moll, MD writes… 2014 promises to be quite a year regarding the new oral anticoagulants. On Jan 8th, 2013 the company Daiichi applied for FDA approval for their drug edoxaban (Savaysa®) for 2 indications: (a)  DVT and PE (venous thromboembolism; VTE) treatment, and (b) non-valvular atrial fibrillation and the prevention of systemic arterial thromboembolism. This application is based on the 2 large phase 3 edoxaban trials, one in VTE, one in A. fib, both published in the New England Journal of Medicine in 2013 [ref 1,2].

Here is a summary of the FDA approval status and application status of the 4 big new oral anticoagulants. Also On Jan 8th, 2014, the brand name of edoxaban was announced: Savaysa (Daiichi press release here).

References

1. The Hokusai-VTE Investigators. Edoxaban versus warfarin for the treatment of symptomatic venous thrmomboembolism. N Engl J Med 2013;369:1406-1415 (Oct 10, 2013).
2. Giugliano RP et al. Edoxaban versus warfarin in patients with atrial fibrillation. N Engl J Med 2013;369(22):2093-104(Nov 28, 2013).

Disclosure: I have consulted for Janssen, Daiichi, and Boehringer Ingelheim.

Last updated: March 14th, 2013