Despite getting a knockback from US regulators this week, AstraZeneca is looking to get European approval for Axanum, which combines aspirin and the firm’s blockbuster antiulcerant Nexium.

Specifically, the Anglo-Swedish drugmaker has submitted a marketing authorisation application in the European Union via the decentralised procedure for Axanum. The product combines low-dose acetylsalicylic acid (ASA) and Nexium (esomeprazole) and AstraZeneca hopes it will be approved for the prevention of cardio- and cerebrovascular events in patients requiring continuous low-dose aspirin treatment who are at risk of developing ASA-associated gastric and/or duodenal ulcers.

The filing is based on two Phase III studies involving more than 3,400 patients, and the company says these have demonstrated the clinical benefit of low-dose ASA plus esomeprazole compared to aspirin plus placebo. AstraZeneca notes that up to 30% of patients with upper gastrointestinal problems discontinue or take deliberate breaks from their low-dose ASA treatment, “which can place them at risk of a potentially life-threatening CV event as early as 8-10 days after discontinuation”.

The submission is part of AstraZeneca’s bid to extend the life cycle through new formulations of Nexium which is a big earner (first-quarter sales were up 3.9% to $1.24 billion). However, the drug is scheduled to go off-patent in May 2014.

The EU filing comes days after the US Food and Drug Administration issued a complete response letter for Axanum. AstraZeneca gave no details about what further information the agency requires but said it is currently evaluating the letter and will continue discussions with the FDA “to determine next steps”.