FDA Approves Bevespi Aerosphere for Patients With COPD

Treatment demonstrates superior improvement in lung function versus mono-components and placebo

The FDA has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol (AstraZeneca) for the long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is the only long-acting dual bronchodilator delivered through a pressurized metered-dose inhaler.

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). The FDA approval was based on data from the PINNACLE 1 and PINNACLE 2 trials, and from a safety extension study, PINNACLE 3. Overall, the phase 3 pivotal program enrolled more than 3,700 patients with moderate to very severe COPD.

Bevespi Aerosphere demonstrated significant (P < 0.001) improvements in lung function, as measured by the change from baseline in the morning predose trough forced expiratory volume in one second (FEV1) at 24 weeks compared with its individual components (glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg) and placebo, all dosed twice daily.

Bevespi Aerosphere also demonstrated a significant improvement compared with placebo on secondary endpoints of peak FEV1 within two hours post-dose, and rescue medication usage.

The most common adverse events with Bevespi Aerosphere compared with placebo included urinary tract infection (2.6% vs. 2.3%, respectively) and cough (4.0% vs. 2.7%).

COPD is a progressive disease that can cause obstruction of airflow in the lungs, resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms, such as breathlessness, are important to the management of COPD. It is estimated that 80% of patients experience symptoms at night, such as an irritative cough, difficulty breathing, and frequent nocturnal awakenings.

Source: AstraZeneca; April 25, 2016.