US patients with chronic obstructive pulmonary disease have been given a new option for maintenance treatment of airflow obstruction with the approval of AstraZeneca’s Bevespi Aerosphere, the first product approved that employs the firm’s novel co-suspension technology.
Bevespi Aerosphere is a twice-daily, fixed-dose dual bronchodilator combining glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 agonist (LABA) in a single inhaler.
The US Food and Drug Administration cleared its use on the back of data from the 3,700-patient PINNACLE trial programme, which showed that it achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks versus its individual components and placebo, all dosed twice daily.
Bevespi Aerosphere also hit secondary targets by demonstrating a significant improvement versus placebo on secondary endpoints of peak FEV1 within two hours post-dose, and rescue medication usage, while its safety profile was shown to be consistent throughout the programme.
“With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurised metered-dose inhaler, delivered using our unique formulation technology,” said AZ’ chief medical officer Sean Bohen.
“LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, which enables patients to breathe better and may help them be more active.”
The firm’s co-suspension technology enables the consistent delivery of one or more different medicines from a single pressurised metered-dose inhaler (pMDI), providing a stable, homogeneous suspension designed to prevent sedimentation of drug crystals over time and prevent their interaction.
The technology is being applied to a range of AZ’ respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).