With data from a second phase 3 trial, AstraZeneca has finally convinced FDA regulators that its new COPD offering deserves a place on the U.S. market just as a competitor from GlaxoSmithKline does.
The FDA has approved AstraZeneca’s three-in-one inhaler Breztri Aerosphere for the maintenance treatment of COPD, the company said Friday. The drug is a combination of the three ingredients included in AZ’s dual-drug regimens Symbicort and Bevespi.
The approval, which came on AZ’s second try and after go-aheads by authorities in Japan and China, puts the company three years behind GSK’s rival med Trelegy Ellipta.
AZ was hit with an FDA complete response letter in fall 2019. At that time, the company had already reported positive data from the phase 3 Kronos trial. Breztri hit all but one of nine primary endpoints. In a head-to-head comparison against old blockbuster Symbicort and its Aerosphere tech-delivered counterpart PT009, Breztri showed a numerical—not statistically significant—advantage at reducing the rate of sudden worsening of COPD symptoms over a period of 24 weeks.
But the British pharma immediately resorted to results from a second phase 3 program, dubbed Ethos, for its second try.
According to detailed data recently published in The New England Journal of Medicine, Breztri, over 52 weeks, significantly reduced sudden instances of symptom worsening by 24% compared with Bevespi and by 13% against PT009. The results were similar with half the level of Breztri’s budesonide component, at 160μg strength. The final FDA-approved Breztri has 160μg of the corticosteroid.