The German Institute for Quality and Efficiency in Health Care (IQWiG) examined in a dossier assessment whether Lixiana (edoxaban) from Japanese drug major Daiichi Sankyo (TYO: 4568) offers an added benefit over the appropriate comparator therapy.
In conclusion, an indication of considerable added benefit compared with vitamin K antagonists was derived for the prevention of stroke and systemic embolism: Stroke, bleeding and severe side effects occurred less frequently under edoxaban. For the second therapeutic indication, suitable analyses were lacking in the company’s dossier, the IQWiG said.
Lixiana has been approved since June 2015 for two therapeutic indications in adults: on the one hand, for prevention of stroke and systemic embolism in adults with non-valvular atrial fibrillation (NVAF) with other risk factors for stroke; on the other, for treatment and prevention of deep vein thrombosis and pulmonary embolism.
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