AstraZeneca applies for EU approval of new Axanum drug

AstraZeneca has submitted a European marketing authorisation application for Axanum, a new combination therapy for the prevention of cardio- and cerebrovascular (CV) events.

The product combines the active ingredient of Nexium with low-dose acetylsalicylic acid (ASA) and is designed for patients who require continuous low-dose ASA treatment and are at risk of developing associated gastric or duodenal ulcers.

This application has been submitted following the completion of two phase III studies, which demonstrated the efficacy of the treatment when compared to placebo control groups.

It is hoped that Axanum will provide a solution for patients who suffer from gastrointestinal problems as a result of ASA therapy which cause them to discontinue treatment.

AstraZeneca identified this as a potentially life-threatening trend, as patients who stop their ASA treatment regimes are at risk of suffering a fatal CV event within eight to ten days.

Last week, the company announced the appointment of Martin Mackay as its president of research and development, with the executive joining AstraZeneca from Pfizer.