The US FDA has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or emphysema, according to manufacturer AstraZenaca. The product is not indicated to treat asthma or for the relief of acute bronchospasm, the company noted.
Bevespi Aerosphere (glycopyrrolate/formoterol fumarate 9 mcg/4.8 mcg) 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).
The FDA approval is based on the PINNACLE trial program, which demonstrated that Bevespi Aerosphere achieved statistically significant improvement in morning pre-dose forced expiratory volume in 1 second (FEV1) at 24 weeks (p < 0.001) versus its mono-components and placebo.
Bevespi Aerosphere is the first product approved using AstraZeneca’s Co-Suspension Technology. This technology enables consistent delivery of one or more different medicines from a single pMDI. The technology is being applied to a range of AstraZeneca respiratory inhaled combination therapies currently in clinical development, such as the fixed-dose triple combination of LAMA/LABA/Inhaled corticosteroid (PT010).
Sean Bohen, Executive Vice-President, Global Medicines Development and Chief Medical Officer, said: “With the approval of Bevespi Aerosphere we are pleased to provide patients with the first LAMA/LABA in a pressurized metered-dose inhaler, delivered using our unique formulation technology. LAMA/LABAs are emerging as a preferred treatment option for many COPD patients. This class aims to provide maximum bronchodilation, enabling patients to breathe better and may help them be more active.”
LABAs, such as formoterol fumarate, increase the risk of asthma-related death, AstraZenaca noted. The most common adverse reactions with Bevespi Aerosphere were urinary tract infection and cough.