The United States Food and Drug Administration (US FDA) has approved budesonide/glycopyrrolate/formoterol fumarate (BGF; BREZTRI Aerosphere, AstraZeneca) as the first single-inhaler triple-combination maintenance therapy for asthma in adult and pediatric patients 12 years of age and older, the company announced April 28, 2026. The decision marks the second approved indication for BGF, which received FDA clearance for chronic obstructive pulmonary disease (COPD) in adults in 2020.¹
"Despite the availability of dual maintenance therapy, many patients are still at risk for exacerbations and experience daily breathing difficulties, reduced lung function and the ongoing fear of worsening symptoms," said Njira Lugogo, MD, Clinical Professor in the Division of Pulmonary and Critical Care Medicine at the University of Michigan.1 The approval represents a potential option for the estimated half of the 27 million US asthma patients who remain inadequately controlled on existing inhaled corticosteroid/long-acting beta₂-agonist (ICS/LABA) regimens.3
Trial Overview
The FDA approval was supported by data from the KALOS and LOGOS trials, twin Phase III, randomized, double-blind, double-dummy, parallel-group, multicenter studies enrolling approximately 4,300 patients with asthma, including those with and without a recent exacerbation.2 Both trials had variable treatment durations of 24 to 52 weeks.
For the US regulatory submission, the primary efficacy endpoint was change from baseline in forced expiratory volume in 1 second (FEV₁) area under the curve from 0 to 3 hours (AUC₀₋₃) at week 24, compared with PT009, an Aerosphere-formulated budesonide/formoterol fumarate dual comparator. The least squares mean differences in morning pre-dose trough FEV1 and FEV1 AUC0–3 over 24 weeks for BGF 28.8 versus the pooled budesonide–formoterol comparators were 76 mL (95% CI, 57–94; P <.0001) and 90 mL (95% CI, 72–108; P <.0001), respectively, with BGF 28.8 favored across all regulatory comparisons for both lung function endpoints. In the primary pooled exacerbation analysis, BGF 28.8 reduced the annualized severe exacerbation rate versus the combined budesonide–formoterol arms (incidence rate ratio, 0.86; 95% CI, 0.76–0.97; P = .012) and versus the suspension formulation specifically (IRR, 0.82; 95% CI, 0.71–0.94; P = .0043); the comparison versus the Aerosphere co-suspension formulation alone did not reach significance (IRR, 0.90; 95% CI, 0.78–1.03; P = .12).2
Adverse events were reported in 53.2% of BGF 28.8 recipients, 60.0% with BGF 14.4, 55.2% with budesonide–formoterol Aerosphere, and 58.4% with the suspension formulation; no treatment-related deaths occurred.2 The investigators noted that benefits were observed regardless of recent exacerbation history, suggesting BGF may be appropriate for escalation in inadequately controlled patients without requiring a preceding acute episode on ICS–LABA.
Clinical Context
Asthma affects approximately 262 million people globally and 27 million in the US, with nearly 10 million acute attacks occurring annually in the US alone.3 A substantial proportion of patients with moderate-to-severe asthma remain inadequately controlled on standard ICS/LABA dual therapy, sustaining persistent airflow limitation, exacerbations, and diminished quality of life. Uncontrolled asthma carries risks of hospitalization and, in severe cases, death. The approved asthma indication for BGF targets patients whose disease burden persists despite dual inhaled maintenance therapy, a population with recognized unmet need.
Drug and Drug-Class Background
BGF for asthma (BGF 320/18/9.6 µg) combines budesonide, an inhaled corticosteroid (ICS), with formoterol fumarate, a long-acting beta₂-agonist (LABA), and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered via pressurized metered-dose inhaler (pMDI) using Aerosphere technology. The ICS/LABA combination addresses airway inflammation and bronchoconstriction, while the addition of the LAMA provides further bronchodilation through a complementary, anticholinergic mechanism. BREZTRI for COPD (BGF 320/36/9.6 µg) received FDA approval in July 2020 and has since been prescribed to more than 6.8 million patients globally.¹ Regulatory submissions for the asthma indication are currently under review in the EU, Japan, and China.
Limitations and Next Steps
The comparator used in the FDA submission was a dual ICS/LABA in Aerosphere formulation (PT009), which limits direct extrapolation to other ICS/LABA devices or formulations. Long-term data beyond 52 weeks, pediatric-specific subgroup outcomes, and performance relative to biologic therapies remain areas for future investigation. Regulatory filings in the EU, Japan, and China are pending review.
References
Papi A, et al. Budesonide/glycopyrronium/formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin phase 3, randomised, double-blind, double-dummy, parallel-group, multicentre trials. Lancet Respir Med. 2026. DOI: 10.1016/S2213-2600(25)00457-6
