AstraZeneca’s winning of approval for Breztri Aerosphere (ingredient: budesonide/glycopyrronium/formoterol) is expected to intensify competition in the three-in-one inhalers for chronic obstructive pulmonary disease (COPD).

The British drugmaker announced on Friday that the U.S. FDA has granted the nod for Breztri as the maintenance treatment for COPD. With the marketing license, Breztri has become a competitor against GSK’s Trelegy Ellipta (fluticasone/umeclidinium/vilanterol).

GSK obtained approval for Trelegy as the first three-in-one COPD inhaler in the U.S. in September 2017. Trelegy sold 158 million pounds ($664 million) globally in 2019, and 193 million pounds in the first quarter of 2020 alone.

The FDA’s green light for Breztri was based on the results of phase-3 ETHOS and KRONOS trials. The two studies are part of the 11 phase-3 ATHENA global trials on 15,500 patients around the world.

The ETHOS study evaluated Breztri’s efficacy and safety compared with AZ’s other two-in-one inhaler Bevespi Aerosphere (glycopyrronium/formoterol) and PT009 (budesonide/formoterol) at the 52nd week of treatment. The primary endpoint was the rate of moderate or severe COPD exacerbations in a year.

The results showed that the Breztri-treated group demonstrated a meaningfully low exacerbation, compared to the other two-in-one inhalers.

The Breztri group was divided into two -- budesonide-320μg arm and budesonide-160μg group. Each group’s exacerbation rate was 1.08 and 1.07, respectively. In contrast, Bevespi-treated patients’ exacerbation rate stood at 1.42, and the PT009 group, 1.24.

The outcomes have been released in the New England Journal of Medicine on July 2.

The KRONOS trial compared Breztri with the other two inhalers mentioned above, in moderate-severe COPD patients, regardless of the exacerbations' history. The primary endpoint was a pulmonary function parameter at week 24.

The results showed that the Breztri group had a meaningful improvement in lung functions measured by an index called “FEV1 AUC0-4,” compared to the PT009 group. However, compared to the Bevespi group, Breztri failed to demonstrate meaningful improvement. The Lancet published the outcomes in October 2018.

GSK is seeking to expand the indication of Trelegy to asthma in the U.S. and Europe.

In the phase-3 Captain trial, Trelegy effectively improved lung functions, compared with GSK’s two-in-one inhaler Breo Ellipta (fluticasone/vilanterol).