AstraZeneca files Axanum in the EU
This article was originally published in Scrip
Executive Summary
AstraZeneca has filed its combination therapy Axanum (esomeprazole plus aspirin) in the EU for the prevention of cardio- and cerebrovascular events in patients requiring continuous low-dose aspirin who are at risk of developing aspirin-associated gastric and/or duodenal ulcers. The announcement of the approval application, which has been made through the decentralised procedure, follows hot on the heels of a rejection of Axanum for the same indication in the US (scripnews.com, 1 June 2010).