Positive agreement received for approval of AXANUM (low-dose ASA/esomeprazole) in Europe

AstraZeneca today 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. AXANUM is indicated for prevention of cardiovascular (CV) events such as heart attack or stroke, in high-risk CV patients in need of daily low-dose ASA treatment and who are at risk of gastric ulcers.

Low-dose ASA (commonly known as aspirin) is recommended mainstay therapy for patients with high-risk for cardiovascular events. About one third of these patients are also at increased risk of stomach ulcer. Low-dose ASA further increases the risk for gastric ulcers and gastrointestinal bleeding. In fact, the most common reason for stopping low-dose ASA treatment is upper gastrointestinal problems. The consequences of interrupting low-dose ASA treatment can be severe, increasing the risk of a heart attack or stroke as early as eight to 10 days later.

AXANUM is the only medicine that ensures every single pill of low-dose ASA comes with built-in protection against gastric ulcers. That means AXANUM has the potential to provide continuous CV protection in this patient population.

The EU decision took place under the decentralised procedure (DCP), with Germany acting as reference member state. This process is now followed by national approvals and local pricing and reimbursement discussions.

Tony Zook, Executive Vice President of AstraZeneca’s Global Commercial Organisation said: “AstraZeneca has had some significant regulatory approvals this year, and we’re pleased with this positive agreement for AXANUM in Europe. 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.”