Please login to the form below

Not currently logged in
Email:
Password:

Daiichi Sankyo VTE drug approved

Japan has granted first marketing approval for Lixiana (edoxaban) for the prevention of venous thromboembolism (VTE)

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.

27th April 2011

Share

COVID-19 Updates and Daily News

Featured jobs

PMHub

Add my company
Madmicrobe Studios

MadMicrobe is an award-winning team of animators and science experts creating photo real life-science animation content for the healthcare and...

Latest intelligence

US biosimilars
The US celebrates five years of biosimilars on the market – a look to the past, present and future
Why the success of biosimilars in the US has been mixed...
Harness the power of data to map new patient pathways
Oli Hudson, of Wilmington Healthcare, explains why pharma needs to put data at the heart of its bid to support the NHS Reset...
What NORD’s RareInsights® 30-year comparative analysis means to us and our clients at OPEN Health
...

Infographics