Daiichi Sankyo has received a first marketing approval, in Japan, for its anticoagulant edoxaban.
The drug, which will be sold as Lixiana, has been given the green light by the Japanese Ministry of Health, Labour and Welfare in Japan. Specifially, edoxaban, a once-daily oral, direct factor Xa inhibitor has been approved for the prevention of venous thromboembolism (VTE) in patients with total knee and hip arthroplasty and hip fracture surgery.
Daiichi Sankyo chief executive Joji Nakayama said the firm is confident edoxaban “will make a great contribution to VTE prevention after major orthopaedic surgery”, noting that the company is exploring the potential for the drug “in several other indications”. Kazunori Hirokawa, the firm’s R&D chief, added that “based on the data we have seen so far, edoxaban has been shown to be an effective anticoagulant with a predictable pharmacokinetic and pharmacodynamic profile, which allows for a convenient, once-daily dosing”.
He went to say that the encouraging data “support the potential for edoxaban in anticoagulation management while being effective against thromboembolic events”. The most lucrative of the indications the drug is being evaluated for is stroke prevention in atrial fibrillation patients.
A Phase III study involving more than 21,000 patients in 46 countries is the largest AF trial to date, Daiichi Sankyo said. It is also running a late-study in the treatment and prevention of recurrent VTE, involving 7,500 patients in 450 clinical sites in 40 countries.
The anticoagulant market is becoming a competitive one and the latest wave of new drugs is headed by Boehringer Ingelheim’s oral direct thrombin inhibitor Pradaxa (dabigatran etexilate), which is approved in the USA and Japan for the prevention of stroke in patients with AF. In terms of factor Xa inhibitors, edoxaban will likely go up against Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) and Pfizer/Bristol-Myers Squibb’s apixaban.