AZ’s Nexium/aspirin combination gets EU thumbs-up

AstraZeneca have announced that Axanum, a fixed dose combination of 81 mg low-dose ASA (acetylsalicylic acid) and 20 mg esomeprazole, has received positive agreement for approval in 23 European Union member countries and in Norway.

The combination is indicated for prevention of cardiovascular events such as heart attack or stroke, in high-risk patients in need of daily low-dose ASA (acetylsalicylic acid) treatment and who are at risk of gastric ulcers. Aspirin is recommended mainstay therapy for patients with high-risk for CV events but on its own increases the risk for ulcers and gastrointestinal bleeding.

The Anglo-Swedish drug maker notes that Axanum is ‘the only medicine that ensures every single pill of low-dose ASA comes with built-in protection against gastric ulcers’, thus providing continuous CV protection in this patient population. Tony Zook, head of AstraZeneca’s global commercial organisation said: “we will now work with relevant health authorities to secure reimbursement decisions and get onto formularies to bring this medicine to patients as soon as possible.”

The EU decision took place under the decentralised procedure with Germany acting as reference member state.


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