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Thursday, June 10, 2010

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

AstraZeneca04 June 2010 - AstraZeneca announced that it 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... AstraZeneca's Press Release -