The FDA signed off on Daiichi Sankyo's clot-preventing edoxaban, giving the Japanese drugmaker the green light to compete in a crowded market for next-generation anticoagulants.
Daiichi Sankyo's pill, to be sold as Savaysa, is a once-a-day treatment that works by blocking Factor Xa, a protein that helps blood coagulate. The FDA's blessing clears it for use in reducing stroke in patients with atrial fibrillation, an irregular heartbeat, and as a treatment for deep vein thrombosis and pulmonary embolism, in which clots block blood flow around the body.
Now the pill will contend with a broad class of oral treatments that Big Pharma hopes can unseat tried and cheap warfarin in the anticoagulant space. Leading the way is Bayer and Johnson & Johnson's once-daily ($JNJ) Xarelto, followed by twice-a-day treatments Eliquis, from Bristol-Myers Squibb ($BMY) and Pfizer ($PFE); and Pradaxa, made by Boehringer Ingelheim.
In pivotal trials involving more than 21,000 patients, Daiichi Sankyo's drug measured up to warfarin in reducing risks of stroke and major blood clots but failed to prove superior to the long-generic treatment. However, edoxaban cut back on clotting without the major bleeding risks that make warfarin tough to take for many patients, giving Daiichi Sankyo a case to make with doctors and payers when it launches the drug next month.
"The approval of Savaysa demonstrates our commitment to providing new treatment options for cardiovascular diseases with significant unmet needs and reinforces our leadership in Factor Xa-inhibition research, which began more than 30 years ago," CEO Joji Nakayama said in a statement.
Savaysa picked up Japanese approval in September.
- read the FDA's release
- here's Daiichi Sankyo's statement