BGF Triple Therapy FDA Approval Expands Asthma Options for Underserved Patients, With Juanita Mora, MD

The FDA's April 28, 2026 approval of budesonide/glycopyrrolate/formoterol fumarate (BGF; Breztri Aerosphere, AstraZeneca) for asthma maintenance in patients aged 12 years and older marks the first time a single-inhaler triple combination therapy has been available in the United States for this indication.

HCPLive caught up with Juanita Mora, MD, an allergist-immunologist at Chicago Allergy Center, attending physician at Advocate Illinois Masonic Medical Center in Chicago, Illinois, and board director of American Lung Association, to learn more about the approval, which she sees as an overdue expansion of options for a large and underserved patient population.

BGF combines budesonide, an inhaled corticosteroid (ICS), with formoterol fumarate, a long-acting β₂-agonist (LABA), and glycopyrrolate, a long-acting muscarinic antagonist (LAMA), delivered via pressurized metered-dose inhaler using AstraZeneca's Aerosphere co-suspension technology. The addition of the LAMA to the established ICS/LABA backbone provides a complementary bronchodilatory mechanism through anticholinergic airway smooth muscle relaxation, addressing both the inflammatory and obstructive components of asthma in a single device. Breztri was previously approved for chronic obstructive pulmonary disease (COPD) in adults in July 2020, giving the regimen a substantial real-world safety and efficacy track record — a feature Mora noted provides additional confidence as the drug transitions into the asthma setting.

The approval was supported by data from the KALOS and LOGOS trials, twin phase 3, randomized, double-blind, double-dummy, multicenter studies enrolling approximately 4,300 patients with asthma inadequately controlled on medium- or high-dose ICS/LABA therapy, with treatment durations of 24 to 52 weeks. The least squares mean differences in morning pre-dose trough FEV₁ and FEV₁ AUC₀₋₃ over 24 weeks for BGF 28.8 μg 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. In the primary pooled exacerbation analysis, BGF 28.8 μg 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). Investigators noted that benefits were observed regardless of recent exacerbation history, suggesting BGF may be appropriate for escalation without requiring a preceding acute episode on ICS/LABA. The most common adverse events were nasopharyngitis, pneumonia, and headache; no treatment-related deaths occurred.

Mora framed the clinical significance of the approval around access as much as mechanism. An estimated 27 million Americans have asthma, with a substantial proportion — representing as many as half of those on existing inhaled maintenance therapy — remaining inadequately controlled on dual ICS/LABA regimens. For patients in that group who have not yet been able to see a specialist and initiate biologic therapy, BGF provides an additional pharmacologic option within the inhaled maintenance category that can be initiated and managed in primary care or general allergy settings. She emphasized this pathway as especially relevant for Hispanic and other underserved communities with limited specialty access, a patient population she serves directly in Chicago and one she has described as bearing a disproportionate burden of poorly controlled asthma.

“I think it's going to really especially for patients who maybe don't have as much access to a specialist where they can get a biologic,” Mora said. “[It’s] a wonderful option to open the doors for better control of our asthmatics.”

Mora has no relevant disclosures to report.

References

1. AstraZeneca. FDA approves BREZTRI AEROSPHERE® (budesonide/glycopyrrolate/formoterol fumarate) for asthma. Press release. April 28, 2026.

2. Bateman ED, O'Byrne PM, Rabe KF, et al. Budesonide/glycopyrronium/formoterol fumarate dihydrate versus budesonide/formoterol in patients with inadequately controlled asthma (KALOS and LOGOS): two multicentre, randomised, double-blind, double-dummy, phase 3 studies. Lancet Respir Med. 2026. doi:10.1016/S2213-2600(25)00457-6