The European Medicines Agency has recommended granting marketing authorisation for the medicinal product Bevespi Aerosphere (glycopyrronium/formoterol fumarate dihydrate) for maintenance treatment in patients with chronic obstructive pulmonary disease (COPD).
Bevespi Aerosphere is a fixed-dose combination of the long-acting beta-2 receptor agonist formoterol fumarate dihydrate and the long-acting muscarinic antagonist glycopyrronium. It will be available as a suspension for inhalation (7.2 micrograms / 5.0 micrograms).
The safety and efficacy of Bevespi Aerosphere were demonstrated in the PINNACLE-1 and PINNACLE-2 randomised double-blind placebo-controlled phase 3 trials which included 2,103 and 1,615 patients, respectively. In both trials, participants received either glycopyrrolate/formoterol (GP/FF) 18/9.6 μg, GP 18 μg, FF 9.6 μg or placebo all twice daily.
At week 24, differences in change from baseline in morning predose trough FEV1 for GP/FF vs placebo, GP and FF were 150 mL, 59 mL and 64 mL in PINNACLE-1 (all P<.0001 and ml in pinnacle-2 p there were no significant safety findings. the incidence of adverse events was similar between treatment arms.>
The EMA opinion will now be sent to the European Commission for final approval.