British-Swedish drugmaker AstraZeneca has received marketing approval from the European Commission (EC) for Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12mcg).
The company obtained marketing authorisation for the drug to be used as a maintenance bronchodilator treatment, to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD).
Duaklir is a fixed-dose combination of long-acting muscarinic-antagonist (LAMA), Eklira (aclidinium bromide), and long-acting beta-agonist (LABA), formoterol.
AstraZeneca global medicines development executive vice-president Briggs Morrison said: "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."
Approval was based on efficacy and safety data from more than 2,000 patients in 11 clinical trials, conducted in 29 countries worldwide.
Following the strategic business combination of Almirall’s respiratory portfolio, AstraZeneca owns the rights to develop and commercialise Duaklir in the European Union (EU).
The approval allows the company to market Duaklir in both dry powder and pressurised metered dose devices.
AstraZeneca noted that the twice-daily therapy is the only LAMA/LABA combination to show statistically significant improvement in breathlessness compared to individual therapies. It is administered by the Genuair dry powder inhaler device.
Image: AstraZeneca’s R&D site in Mölndal, Sweden. Photo: courtesy of Erik031.