AstraZeneca Receives EU Approval for COPD DrugBy
AstraZeneca reports that Duaklir Genuair (aclidinium bromide/formoterol fumarate 340/12 mcg) has been granted marketing authorization 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).
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 sn LAMA/LABA combination that shows improvement in breathlessness compared to individual therapies and is administered by the Genuair dry-powder inhaler device.
AstraZeneca owns the rights to develop and commercialize 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 is part of AstraZeneca’s strategy in inhaled therapies of providing physicians and patients a choice of products in both dry powder and pressurized metered dose devices.