The triple-combination drug demonstrated a “statistically-significant” reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere and PT009.
Even more impressively, patients only had to take half as much of Breztri Aerosphere to get better results.
“Exacerbations are devastating events for patients and can lead to a permanent loss of lung function,” said Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D.
“The phase III ETHOS trial builds on the phase III KRONOS data which together show Breztri Aerosphere's ability to reduce exacerbation risk in a broad range of patients with COPD, irrespective of whether they have had an exacerbation in the previous twelve months.”
Orphan drug status for Fasenra
In a separate statement, Astra confirmed its Fasenra drug has been granted orphan drug status by the US regulator as a treatment for eosinophilic esophagitis (EoE).
EoE is an allergic inflammatory disease of the oesophagus.
The Food and Drug Administration grants orphan status to drugs that are intended to treat diseases or disorders that affect fewer than 200,000 people in the US.
Because the market is so small, regulators offer companies developing such treatments a number of benefits, such as tax credits, reduced fees and a less onerous approval process.
Shares were up 0.8% to 7,298p.