Astra applies for Axanum approval in EU

Twitter icon
Facebook icon
LinkedIn icon
e-mail icon
Google icon

AstraZeneca has submitted a Marketing Authorization Application (MAA) to the European Union (EU) to gain approval of a combination low-dose acetylsalicylic acid (ASA) and esomeprazole (Nexium) as a treatment to prevent cardiovascular events in patients at risk for ASA-associated gastric or duodenal ulcers.

According to the London-based company, if approved, the proposed trade name for the drug is Axanum and comes in a 81 mg ASA and 20 mg esomeprazole fixed-dose.

Results of two phase III clinical trials, ASTERIX and OBERON that evaluated over 3,400 patients found that patients administered the low-dose ASA plus esomerprazole fared better than those patients administered ASA plus placebo, the company said.