Bevespi Aerosphere disappointing in AERISTO study

AstraZeneca’ Bevespi Aerosphere is allegedly the first and only long-acting muscarinic agonist/ long-acting beta2-agonist with Aerosphere delivery technology. It is a fixed-dose dual bronchodilator that combines the LAMA glycopyrronium and the LABA formoterol fumarate, and already has approval in the US and Canada for the long-term maintenance treatment of airflow obstruction in chronic obstructive pulmonary disease, and is being reviewed by the EMA.
1,119 patients took part in the 24-week phase IIIb trial AERISTO, and were either given two inhalations twice daily of glycopyrronium/formoterol fumarate 7.2/4.8µg through pressurised metered-dose inhaler or one dry powder inhalation once a day of umeclidinium/vilanterol 62.5/25µg. The former was unable to demonstrate superiority against the latter for patients with moderate to very severe COPD.
Dr Colin Reisner, AZ global medicines development head, said: “The efficacy and safety of Bevespi Aerosphere has been established by the Phase III PINNACLE trial programme involving more than 5,000 patients. The performance of Bevespi Aerosphere in AERISTO is inconsistent with previous data. A full analysis is underway to understand and characterise these findings and will be presented at a forthcoming medical meeting.”