Bevespi Aerosphere Approval History
- FDA approved: Yes (First approved April 25th, 2016)
- Brand name: Bevespi Aerosphere
- Generic name: formoterol fumarate and glycopyrrolate
- Dosage form: Inhalation Aerosol
- Company: AstraZeneca
- Treatment for: COPD
Bevespi Aerosphere (formoterol fumarate and glycopyrrolate) is a long -acting beta2-adrenergic agonist (LABA) and anticholinergic combination indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).
The FDA approval of Bevespi Aerosphere was based on results of the PINNACLE phase III pivotal studies (PINNACLE 1, PINNACLE 2, and a safety extension study, PINNACLE 3) which included over 3,700 patients with moderate to very severe COPD. The studies demonstrated that Bevespi Aerosphere achieved statistically significant improvements in lung function as measured by change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its individual components (glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg) and placebo.
Bevespi Aerosphere is administered twice-daily in the morning and in the evening. It is not intended to relieve acute symptoms of COPD, which should be treated with a rescue inhaler such as albuterol.
The most commonly reported side effects include urinary tract infection and cough.
Development History and FDA Approval Process for Bevespi Aerosphere
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