AstraZeneca’s Breztri Aerosphere picks up US approval for asthma

Edited by Robert McTiernan··3 min read

The US FDA has approved Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) for the maintenance treatment of asthma in adults and adolescents aged 12 years and older, marking the first approval of a single-inhaler triple therapy for asthma in the US. The approval represents a second indication for AstraZeneca’s fixed-dose combination product, which was given the nod to treat chronic obstructive pulmonary disease (COPD) in the US in 2020.

Breztri Aerosphere delivers budesonide, an inhaled corticosteroid (ICS), alongside glycopyrrolate, a long-acting muscarinic antagonist (LAMA), and formoterol fumarate, a long-acting beta2-agonist (LABA), at doses of 320/18/9.6 µg per actuation. The combination adds a LAMA component to the ICS/LABA backbone that has formed the standard maintenance regimen for uncontrolled asthma, and the approval covers maintenance use only — the therapy is not indicated for acute symptom relief and does not replace a rescue inhaler. Regulatory filings for the asthma indication are under review in the EU, Japan, and China.

The FDA approval was supported by data from the Phase III KALOS and LOGOS trials, replicate randomized, double-blind, double-dummy, parallel-group studies enrolling approximately 4,300 patients with asthma, with or without a recent exacerbation. Both trials ran for 24 to 52 weeks and assessed Breztri against dual ICS/LABA comparators, including Symbicort (budesonide/formoterol fumarate) and an Aerosphere formulation of budesonide/formoterol fumarate designated PT009. In the data package submitted to the FDA, the primary endpoint was change from baseline in forced expiratory volume in one second (FEV1) area under the curve from 0 to 3 hours at week 24, compared with PT009. Breztri met this endpoint with a statistically significant improvement in lung function. A key secondary endpoint showed a significant improvement from baseline in lung function within five minutes of the first dose. Results from the KALOS and LOGOS trials were published in The Lancet Respiratory Medicine in February 2026. No new safety or tolerability signals were identified relative to the established profile of the molecule.

The approval enters a treatment landscape where approximately 27 million people in the US are living with asthma, according to the US Centers for Disease Control and Prevention, and where a substantial proportion of patients remain uncontrolled despite adherence to dual ICS/LABA maintenance therapy. Uncontrolled asthma is associated with persistent bronchoconstriction, exacerbations, and reduced lung function, with nearly 10 million asthma attacks occurring annually in the US. The addition of a LAMA to ICS/LABA therapy had already been validated in COPD, where triple fixed-dose combinations are standard of care, but the mechanistic rationale for LAMA use in asthma — addressing airway smooth muscle tone through muscarinic receptor antagonism alongside corticosteroid-mediated inflammation control and LABA-driven bronchodilation — had not previously translated into an approved single-inhaler product for this indication.

The AllSci BriefSystematic R&D and deal news. Daily.

The asthma treatment field has seen considerable activity across both inhaled and biologic modalities. Among approved biologics, dupilumab (Dupixent), mepolizumab (Nucala), benralizumab (Fasenra), and tezepelumab (Tezspire) target distinct components of type 2 inflammatory pathways and are indicated for severe or uncontrolled phenotypes. Breztri occupies a different position as an inhaled maintenance therapy applicable across a broader asthma population, including patients without the eosinophilic or allergic phenotypes that define eligibility for most biologics. The pipeline adds further complexity: GSK’s depemokimab, an extended half-life anti-IL-5 antibody with a twice-yearly dosing interval, has Phase III data in severe eosinophilic asthma from the SWIFT-1 and SWIFT-2 trials; Genentech’s astegolimab targets IL-33 in the SOLSTICE program; and Sanofi/Regeneron’s amlitelimab, an anti-OX40L antibody, is in Phase IIb/III development for moderate-to-severe uncontrolled asthma, with potential applicability to non-type-2 phenotypes that remain without approved biologic options.

For AstraZeneca, the approval extends a molecule with an established manufacturing and prescribing infrastructure into a substantially larger patient population than COPD alone. The company has parallel respiratory assets in the biologic space, including tezepelumab (Tezspire), developed with Amgen, and benralizumab (Fasenra), creating a portfolio that spans inhaled and injectable modalities across asthma severity strata. The decision also carries relevance for triple bronchodilator and anti-inflammatory combinations outside COPD, with the KALOS and LOGOS data now underpinning a US label and formally establishing this approach in asthma.

This article was generated with AI assistance and reviewed and edited by the AllSci editorial team Explore more at AllSci News: https://allsci.com/news/