Daiichi Sankyo’s Once-Daily LIXIANA (edoxaban) Approved in the EU

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The FINANCIAL — Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) on June 25 announced that the European Commission (EC) has granted Marketing Authorisation for LIXIANA (edoxaban), an oral, once-daily selective factor Xa-inhibitor, for the prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA) as well as for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

“AF-related stroke as well as DVT and PE create a significant societal and economic health burden. We welcome the European Commission’s approval of LIXIANA, which means physicians and patients may benefit from a new treatment option to effectively manage these debilitating and life-threatening conditions,” said Jan van Ruymbeke, MD, CEO, Daiichi Sankyo Europe GmbH. “Daiichi Sankyo is committed to bringing innovative medicines to patients who need them. Once-daily LIXIANA offers the unique combination of an easy-to-use oral anticoagulant with proven efficacy across a broad range of patients and a better bleeding profile compared to well-managed warfarin.”

Atrial fibrillation (AF), a heart rhythm disorder in which the heartbeat is rapid and irregular, affects over six million Europeans.1 People with AF are at a five-fold increased risk of stroke compared to the general population, with an estimated financial burden of over €38 billion a year.2 VTE, a condition where a blood clot forms in a vein, also represents a major cause of morbidity and mortality, resulting in over 500,000 deaths in the EU each year, according to Daiichi Sankyo Company.

The EC approval is based on two phase 3 clinical trials, ENGAGE AF-TIMI 48 and Hokusai-VTE, which compared treatment with once-daily LIXIANA to warfarin, a current standard of care for stroke prevention in patients with AF or for the treatment and prevention of VTE. These studies represent the largest single comparative trials of a novel oral anticoagulant in these patient populations, involving 21,105 and 8,292 patients, respectively.

In the ENGAGE AF-TIMI 48 study, once-daily LIXIANA showed comparable efficacy (stroke or SEs) in comparison to warfarin (1.18% vs. 1.50% per year, LIXIANA 60 mg vs. warfarin respectively; hazard ratio [HR], 0.79; 97.5% confidence interval [CI], 0.63 to 0.99, p<0.001) and superior safety, significantly reducing major bleeding (2.75% vs. 3.43% per year, LIXIANA 60 mg vs. warfarin respectively; HR, 0.80; 95% CI, 0.71 to 0.91, p<0.001), in a broad range of patients with NVAF.

The Hokusai-VTE study demonstrated that LIXIANA effectively reduces symptomatic recurrent VTE, including DVT and fatal and non-fatal PE risk across a broad range of patients (3.2% vs. 3.5% of patients, LIXIANA 60 mg vs. warfarin respectively; HR, 0.89; 95% CI, 0.70 to 1.13, p<0.001). LIXIANA also showed a significant 19% risk reduction of clinically relevant bleeding in patients with VTE compared to warfarin (8.5% vs. 10.3% of patients, respectively; HR, 0.81; 95% CI, 0.71 to 0.94, p=0.004).

 

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