The US Food and Drug Administration has given the green light to Daiichi Sankyo’s anti-clotting drug edoxaban, to be marketed as Savaysa.
Specifically, the drug has been approved to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation not caused by a heart valve problem. Savaysa also has been given the thumbs-up to treat deep vein thrombosis and pulmonary embolism in patients who have already been treated with an anti-clotting drug for five to ten days.
The AF approval, which includes a boxed warning, is based on a trial of over 21,000 participants which showed Savaysa to be similar to warfarin for the reduction in the risk of stroke but demonstrated significantly less major bleeding. As with other anti-clotting drugs, bleeding is the most serious risk with Savaysa, an oral, once-daily selective factor Xa-inhibitor.
Savaysa, which was approved in Japan in September 2014, will be available in the USA next month, Daiichi Sankyo said. It will go up against two other already-approved factor Xa inhibitors – Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) and Boehringer Ingelheim’s Pradaxa (dabigatran).
