The USFDA has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol as a prolonged, maintenance therapy for chronic obstructive pulmonary disease (COPD) and chronic bronchitis patients with airflow obstruction and/or emphysema. The agency has granted marketing approval based on the PINNACLE clinical trial study that demonstrated statistically significant improvement (FEV1 at 24 weeks) in the study subjects, compared to the placebo group.
Bevespi Aerosphere is a long-acting muscarinic antagonist (LAMA) that is combined with formoterol fumarate, which is a long-acting beta-2 agonist (LABA).
Bevespi Aerosphere is the first approved LAMA/LABA formulation as a metered-dose inhaler to provide maximum bronchodilation in patients who suffer with these types of respiratory problems.
The inhaler is to be commercialized by AstraZeneca.
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