The 2023 “ABE” GOLD treatment guidelines focus mainly on exacerbation risk to determine pharmacological treatment strategies, independent of spirometric value. 

Triple ICS/LABA/LAMA fixed-dose combination therapies delivered through a single inhaler bring convenience to more severe patients. For Breztri Aerosphere’s FDA submission, AstraZeneca included data from the KRONOS study, but the ETHOS trial did not complete primary endpoints until mid-2019. As such, the FDA issued a complete response letter to AstraZeneca, benefiting rival GSK’s marketed Trelegy Ellipta as the only triplet on the US market until, in 2020, Breztri finally gained approval in the US and Europe. 

IL-5 inhibitors have been disappointing in the broader population of more severe COPD patients. However, ongoing studies are evaluating AstraZeneca’s Fasenra and GSK’s Nucala in individuals with high eosinophils. While topline results from Fasenra’s RESOLUTE and Nucala’s MATINEE trials are expected in the coming years, a supplemental Biologics License Application for Sanofi and Regeneron’s dual IL-4 and IL-13 inhibitor Dupixent is now under FDA review following positive data from the Phase III NOTUS and BOREAS studies. 

This Datamonitor Healthcare report contains a Disease Analysis module.