AstraZeneca’s Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) has been shown to have similar therapeutic activity in patients with moderate to very severe chronic obstructive pulmonary disease (COPD) as GlaxoSmithKline’s approved therapy Anoro Elipta (umeclidinium/vilanterol).
Bevespi Aerosphere combines a fixed dose of two bronchodilators — glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta-2 adrenergic agonist (LABA) — in a pressurized metered-dose inhaler (pMDI).
The effectiveness and safety of Bevespi Aerosphere for COPD has been demonstrated in more than 5,000 patients during the Phase 3 PINNACLE clinical program.
Top-line data of the PINNACLE 4 trial (NCT02343458), in 1,756 patients with moderate to very severe COPD showed that the combo therapy could significantly improve lung function compared to single agents.
Positive clinical data from the PINNACLE program supported the drug’s approval by the U.S. Food and Drug Administration in April 2016, and by Health Canada in March 2018 as long-term maintenance therapy for airflow obstruction in COPD.
The European Medicines Agency is reviewing a Marketing Authorization Application for Bevespi Aerosphere, with a decision expected by the end of 2018.
Now, the latest results of the AERISTO Phase 3b trial (NCT03162055) revealed that Bevespi Aerosphere promoted a similar improvement on peak forced expiratory volume in one second (FEV1) — a measure of lung function — as compared to Anoro Elipta. The new therapy, however, was not superior to Anoro Elipta in improving peak FEV1 values.
“The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data,” Colin Reisner, MD, head of respiratory global medicines development at AstraZeneca, said in a press release. “A full analysis is underway to understand and characterize these findings and will be presented at a forthcoming medical meeting.”
The AERISTO trial enrolled 1,119 COPD patients in more than 100 clinical sites across the United States, Canada, and Europe. The study was designed to evaluate the therapeutic activity of Bevespi Aerosphere in comparison with the currently available COPD treatment Anoro Elipta.
Participants were randomized to receive two inhalations twice a day of Bevespi Aerosphere — at a fixed dose of 7.2 micrograms glycopyrrolate and 4.8 micrograms formoterol fumarate — or one inhalation once a day of Anoro Elipta for 24 weeks.
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