AstraZeneca announced that Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted Marketing Authorisation by the European Commission (EC) to be used as a maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Approximately 300 million people around the world live with COPD, a progressive and chronic disease where people find breathing difficult due to limited airflow. Improving the lung function and managing daily symptoms such as breathlessness are important to the management of COPD.
Duaklir is a fixed-dose combination of already-approved Eklira (aclidinium bromide), a long-acting muscarinic-antagonist (LAMA), with the long-acting beta-agonist (LABA) formoterol. The twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies and is administered by the Genuair dry powder inhaler device.
AstraZeneca owns the rights to develop and commercialise Duaklir Genuair in the European Union (EU) following the strategic business combination of Almirall’s respiratory portfolio, which was completed last month. The EU approval of Duaklir Genuair marks an important further step in AstraZeneca's inhaled therapy strategy of providing physicians and patients a choice of products uniquely available in both dry powder and pressurised metered dose devices.
“We are pleased to receive European regulatory approval for Duaklir Genuair as an innovative treatment for patients with COPD. 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.” said Briggs Morrison, executive vice president, global medicines development and chief medical officer at AstraZeneca.
The EU approval of Duaklir Genuair was based on efficacy and safety data from more than 2,000 patients in 11 clinical studies, conducted in 29 countries worldwide. Results showed that Duaklir Genuair demonstrated statistically significant and sustained improvement in the lung function compared to monotherapy, providing a favourable benefit-to-risk profile.
The EC marketing authorisation applies to all member states of the EU and the European Economic Area. Aclidinium bromide/formoterol fumarate will be marketed in Europe by AstraZeneca under the trade name Duaklir Genuair.