Daiichi Sankyo VTE drug approved

Japan's Ministry of Health, Labour and Welfare has granted first marketing approval for Daiichi Sankyo's anticoagulant Lixiana (edoxaban) for the prevention of venous thromboembolism (VTE).

Edoxaban, which is being developed solely by Daiichi Sankyo, is a once-daily oral anticoagulant that specifically, reversibly and directly inhibits the enzyme Factor Xa, a clotting factor in the blood. Results from clinical studies supported the approval of edoxaban for the prevention of venous thromboembolism (VTE) in patients with total knee arthroplasty, total hip arthroplasty and hip fracture surgery.

Joji Nakayama, president and CEO of Daiichi Sankyo, said: "We are pleased to confirm that an exciting milestone has been reached, and we are confident that edoxaban will make a great contribution to VTE prevention after major orthopedic surgery. Daiichi Sankyo also remains committed to exploring the potential for edoxaban in several other indications and has a robust global clinical trial programme."

This development programme is focused on indications including stroke prevention in atrial fibrillation (AF) patients, as well as treatment and prevention of recurrent VTE. In the ENGAGE AF-TIMI 48 study, an ongoing, multinational, randomised, double blind, phase III study, the efficacy and safety of edoxaban in preventing stroke and systemic embolic events in patients with AF are being examined in more than 21,000 patients in 46 countries. This is the largest trial in this indication to date.

Also ongoing is the HOKUSAI VTE study, the largest single, double-blind, randomised, multinational phase III study in the treatment and prevention of recurrent VTE, involving approximately 7,500 patients in 450 clinical sites in approximately 40 countries.

Existing anticoagulants such as heparins and vitamin K antagonists, although effective, have several clinical considerations. Heparins are injectable agents and therefore less suitable for long-term treatment. Vitamin K antagonists are given orally, but are associated with drug and food interactions.

Global head of Daiichi Sankyo's R&D unit, Kazunori Hirokawa said: "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. The data are encouraging and support the potential for edoxaban in anticoagulation management while being effective against thromboembolic events.”

Daiichi Sankyo has more than 25 years' experience conducting research in Factor Xa inhibition and was the first company to study these compounds in humans.