Daiichi Sankyo will file edoxaban on both sides of the Atlantic shortly after the bloodthinner proved as effective and safer than warfarin in a Phase III trial of patients with atrial fibrillation.
The company has presented data on edoxaban, a once-daily oral factor Xa inhibitor, at the American Heart Association meeting in Dallas, from a study involving 21,105 patients across 46 countries. The drug, evaluated in 60mg and 30mg doses, met its primary endpoint of non-inferiority compared to warfarin for the prevention of stroke or systemic embolic events in patients with non-valvular AF.
Daiichi Sankyo R&D chief Glenn Gormley said that the edoxaban clinical trial programme, the largest in the company’s history, has now yielded positive data “in two major diseases”, namely stroke prevention in AF and treatment of acute venous thromboembolism (data from the latter study was presented at the European Society of Cardiology congress in Amsterdam in September). He added that based on the findings from the two Phase III studies, edoxaban filings in both indications will be submitted by the first quarter of 2014.
Edoxaban is already on the market in Japan for VTE, where it is sold as Lixiana, and an AF submission in the country is imminent. The drug will be entering a competitive market where there are already three drugs battling to reduce the dominance of warfarin – two other factor Xa inhibitors, Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s Eliquis (apixaban) and Boehringer Ingelheim’s oral direct thrombin inhibitor Pradaxa (dabigatran etexilate).
