AstraZeneca has received a positive agreement for approval by the European Union (EU) for axanum, an aspirin and esomeprazole combination drug, indicated to prevent cardiovascular (CV) events in high-risk CV patients who need a daily low-dose acetylsalicylic acid (ASA) and who are at risk for gastric ulcers.
The fixed-dose combination of a 91 mg low-dose ASA and 20 mg of esomeprazole has gained a positive agreement for approval in 23 European countries and Norway.
According to London-based AstraZeneca, axanum is currently the only single pill low-dose aspirin that prevents against both CV disease and gastric ulcers.
The decision, which took place under the decentralized procedure, will now undergo national approvals, local pricing and reimbursement discussions. Germany acted as the reference member state during the approval process.