AstraZeneca PLC said the European Commission approved Bevespi Aerosphere inhaler as a maintenance treatment for adults with chronic obstructive pulmonary disease.
Chronic obstructive pulmonary disease, or COPD, is characterized by the obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness.
Bevespi Aerosphere consists of two bronchodilators, substances that make breathing easier by relaxing the muscles in the lungs and widening the airways.
The medication, delivered through a pressurized metered-dose inhaler, or pMDI, and contains glycopyrronium, a long-acting muscarinic antagonist, and formoterol fumarate, a long-acting beta2-agonist.
A pMDI, unlike a dry powder inhaler, uses a chemical propellant to push medication out of the inhaler and into the lungs.
U.K.-based AstraZeneca said Bevespi Aerosphere is the first therapy in its class to be approved by the European Commission, having received the European Medicines Agency's backing in October.
The approval is based on the results of several phase 3 studies, which involved more than 5,000 patients with moderate to very severe COPD.
The company is also testing a triple combination therapy, PT010, containing budesonide, a steroid, as well as glycopyrronium and formoterol fumarate.