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Bevespi Aerosphere Approval History

FDA Approved: Yes (First approved April 25, 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

DateArticle
Apr 25, 2016Approval Bevespi Aerosphere Approved by the FDA for Patients with COPD
Mar 18, 2015AstraZeneca announces positive Phase III top-line results for PT003 from the PINNACLE 1 and PINNACLE 2 studies in COPD
Jan  6, 2012Pearl Therapeutics Announces Successful Completion of Phase 2b Safety and Efficacy Studies of COPD Combination, PT003

Further information

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