AstraZeneca receives EU approval for Duaklir Genuair

AstraZeneca has been granted European Commission approval for Duaklir Genuair, its new chronic obstructive pulmonary disease (COPD) therapy.

The drug has been granted marketing authorisation for use as a maintenance bronchodilator treatment to relieve symptoms in adult patients with COPD. It is a fixed-dose combination of Eklira plus formoterol.

It represents the only LAMA/LABA combination therapy to show statistically significant improvement in breathlessness compared to individual therapies and is administered via the Genuair dry powder inhaler device.

EU approval of Duaklir Genuair was based on efficacy and safety data from more than 2,000 patients in 11 clinical studies. Results showed that Duaklir Genuair demonstrated statistically significant and sustained improvement in lung function compared to monotherapy.

Briggs Morrison, executive vice-president for global medicines development and chief medical officer at AstraZeneca, said: "Patients need treatments that can help to improve their lung function and allow them to better manage the daily and debilitating symptoms of their condition, in turn improving their overall quality of life."

This comes after the firm last month received a recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use for Lynparza, its promising new therapy for ovarian cancer.