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AstraZeneca’s Duaklir Genuair gets marketing approval in Europe for COPD

AstraZeneca has received marketing authorisation from the European Commission (EC) for its Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12mcg) to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).

AstraZeneca Headquarters London

Duaklir is a fixed-dose combination of Eklira (aclidinium bromide), a long-acting muscarinic-antagonist (LAMA), with the long-acting beta-agonist (LABA) formoterol.

Administered by the Genuair dry powder inhaler device, the twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies.

Around 300 million people across the world live with COPD, which is a progressive and chronic disease where people find breathing difficult due to limited airflow.

AstraZeneca Global Medicines Development executive vice-president and chief medical officer Briggs Morrison 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."

The company owns the rights to develop and commercialize Duaklir Genuair in the EU after completing the strategic business combination of Almirall’s respiratory portfolio last month.

The approval was based on efficacy and safety data from more than 2,000 patients in 11 clinical trials, conducted in 29 countries across the world.

Results from these trials showed that Duaklir Genuair improved the lung function compared to monotherapy, providing a favourable benefit-to-risk profile.


Image: AstraZeneca headquarters in London, UK. Photo: courtesy of AstraZeneca plc.