AstraZeneca Submits Marketing Authorisation Application To European Union For Cardiovascular Drug Axanum

AstraZenecaAstraZeneca has submitted a Marketing Authorisation Application (MAA) in the European Union via the Decentralised Procedure (DCP) for a product combining low-dose ASA (acetylsalicylic acid) and the active ingredient of Nexium (esomeprazole) for the prevention of cardio- and cerebrovascular (CV) events in patients requiring continuous low-dose ASA treatment who are at risk of developing ASA-associated gastric and/or duodenal ulcers. Pending approval, the proposed trade name for the product is Axanum.

Low-dose ASA, commonly known as aspirin, is a mainstay of therapy for patients at high risk of a CV event such as myocardial infarction or stroke. However, upper GI problems (including symptoms, ulcers and ulcer-related complications) are common reasons for discontinuing low-dose ASA therapy. Up to 30% of patients with upper GI 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.

Two phase III studies, ASTERIX and OBERON, including more than 3,400 patients, have demonstrated the clinical benefit of low-dose ASA plus esomeprazole compared to low-dose ASA plus placebo in patients who required low-dose ASA treatment and had an increased risk for ulcer development. ASTERIX reported that esomeprazole 20 mg once daily was significantly more effective compared to placebo in preventing gastric and/or duodenal ulcers and associated upper GI symptoms in this patient group. OBERON showed that acid-suppressive therapy with esomeprazole 20mg or 40mg given daily is effective in preventing the occurrence of gastric/duodenal ulcers as well as upper GI symptoms in patients at increased risk of ulcer development during low-dose ASA therapy.

About Axanum TM
Axanum is a fixed-dose combination containing low-dose ASA (acetylsalicylic acid) and the active ingredient of the PPI Nexium (esomeprazole, formulated as enteric coated pellets) developed by AstraZeneca for the prevention of cardio- and cerebrovascular (CV) events in patients requiring continuous low-dose ASA treatment, and at risk for developing ASA associated gastric and/or duodenal ulcers. In EU, the fixed-dose combination contains 81 mg ASA/20mg esomeprazole.

About AstraZeneca
AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialisation of prescription medicines. As a leader in gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease medicines, AstraZeneca generated global revenues of US $32.8 billion in 2009. For more information please visit: