2025 was a defining year for asthma care, marked by regulatory progress, late-stage clinical advances, and a continued shift toward precision, inflammation-driven management. Building on momentum from prior biologic successes, the field expanded beyond injectables and maintenance inhalers, with new evidence supporting oral, inhaled, and rescue-based strategies aimed at reducing exacerbations, steroid exposure, and day-to-day disease burden across asthma severities.

Regulatory milestones underscored this evolution. The FDA cleared an investigational new drug application for frevecitinib, an inhaled dry powder therapy designed for patients with asthma inadequately controlled on standard maintenance treatment, while the expanded FDA approval of albuterol/budesonide (Airsupra) to adults with mild asthma extended anti-inflammatory rescue therapy across the full disease spectrum.

At the same time, a steady stream of clinical data reinforced asthma’s increasingly nuanced, endotype-driven landscape. Late-stage trials and post hoc analyses highlighted meaningful gains in lung function, small airway physiology, and steroid reduction with therapies such as dupilumab, tezepelumab, dexpramipexole, and rezpegaldesleukin, while nonpharmacologic interventions like pulmonary rehabilitation demonstrated measurable anti-inflammatory effects in selected patients. Complementary features and expert discussions placed these advances within a broader environmental and public health context, as worsening air quality and wildfire smoke continued to shape asthma risk, management, and outcomes, together defining 2025 as a year of expansion, integration, and clearer direction in asthma care.

FDA News

FDA Clears IND for Frevecitinib Asthma Inhaler

On January 29, the FDA has cleared Kinaset Therapeutics’ investigational new drug (IND) clearance for frevecitinib (KN-002), a novel inhaled dry powder therapeutic in development for patients with asthma that remains inadequately controlled by standard of care inhaled maintenance therapies.

FDA Expands Albuterol/Budesonide Label to Adults With Mild Asthma

On October 1, 2025, AstraZeneca announced FDA approval of a supplemental new drug application for albuterol/budesonide (Airsupra), expanding its indication to include adults with mild asthma. Based on results from the phase 3b BATURA trial, the therapy reduced the risk of severe exacerbations by nearly half compared with albuterol and lowered annual systemic steroid use, while maintaining a favorable safety profile. The update builds on prior evidence from the MANDALA and DENALI trials, further supporting Airsupra as the first anti-inflammatory rescue option across asthma severities.

Data Readouts

Dupilumab Improves Small Airway Dysfunction in People With Type 2 Asthma

Dupilumab improved small airway dysfunction (SAD) among a population with type 2 high moderate-to-severe asthma, which could explain improvements in disease control, according to a post hoc analysis of the Phase 4 VESTIGE study presented at the 2025 AAAAI/WAO Joint Congress. Those treated with dupilumab reported significant improvements in SAD as measured by peripheral airway resistance and compliance.

Pulmonary Rehabilitation Reduces Type 2 Inflammation in High Inflammation Asthma

Pulmonary rehabilitation (PR) was shown to meaningfully reduce airway inflammation in people with asthma who began treatment with elevated FeNO, with the high-FeNO group experiencing a 40% drop in levels during the 3-week program. Improvements in asthma control and exercise capacity occurred across all baseline FeNO categories, but the anti-inflammatory effect was exclusive to those with high initial FeNO.

Tezepelumab Drastically Reduces OCS Use for Asthma in Open-Label Trial

Nearly all patients with severe, OCS-dependent asthma in the WAYFINDER trial were able to lower their daily steroid dose to 5 mg or less after 52 weeks of open-label tezepelumab, and half fully discontinued OCS while maintaining asthma control. These improvements were consistent across inflammatory subgroups, though the absence of a control arm makes the magnitude of benefit harder to interpret.

Dexpramipexole Oral Add-On for Asthma Significantly Improves Lung Function Over Placebo

Dexpramipexole significantly improved lung function and reduced eosinophil levels compared with placebo as an add-on oral therapy in people with eosinophilic asthma, according to positive topline results from Areteia Therapeutics’ phase 3 EXHALE-4 study. The findings highlight the potential for dexpramipexole to become the first approved oral treatment for eosinophilic asthma, offering a more convenient option alongside existing inhaled and biologic therapies.

Rezpegaldesleukin Shows Strong Phase 2b Results for Atopic Dermatitis, Asthma

Rezpegaldesleukin demonstrated significant improvements in atopic dermatitis severity and meaningful gains in asthma control in a phase 2b trial, supporting its dual potential across inflammatory skin and airway disease. The findings suggest that selectively enhancing regulatory T-cell activity may benefit patients with AD and comorbid asthma, particularly those with partially controlled or uncontrolled disease.

Features/Podcasts

Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management

In this HCPLive expert discussion moderated by Joseph Khabbaza, MD, clinicians examine how the FDA approval of mepolizumab for eosinophilic COPD could mark a turning point in a field long limited to symptom-focused therapies. Drawing on phase 3 MATINEE data, the panel highlights its potential to reduce exacerbations, limit systemic steroid exposure, and usher COPD care toward a more asthma-like, biomarker-driven precision model.

2025 State of the Air: Dangers of the Air We Breathe with George Thurston, ScD

The American Lung Association’s latest State of the Air report shows that nearly half of Americans live in areas with unhealthy air, as worsening ozone and particle pollution, in part driven by heat and wildfires, continues to threaten respiratory and cardiovascular health. In this episode, air pollution expert George Thurston, ScD, breaks down the report’s key findings and explains how both acute and cumulative exposures, along with major monitoring gaps, are shaping health risks across US communities.

After the Smoke: Wildfire Cleanup & Air Quality Concerns with Afif El-Hasan, MD

As wildfire frequency and severity rise worldwide, their impact on air quality and respiratory health has become an urgent concern in pulmonary care. In this episode of Lungcast, Albert Rizzo, MD, and Afif El-Hasan, MD, discuss both the immediate and long-term health risks of wildfire smoke—particularly for vulnerable populations—and outline practical steps patients and communities can take to reduce exposure and protect lung health.

References

1. Johnson V. FDA Clears IND for Frevecitinib Asthma Inhaler. Article. HCPLive. January 30, 2025. https://www.hcplive.com/view/fda-clears-ind-frevecitinib-asthma-inhaler

2. Johnson V. FDA Expands Albuterol/Budesonide Label to Adults With Mild Asthma. Article. HCPLive. September 18, 2025. https://www.hcplive.com/view/fda-expands-albuterol-budesonide-label-adults-mild-asthma

3. Johnson V. Dupilumab Improves Small Airway Dysfunction in People With Type 2 Asthma. Article. HCPLive. January 18, 2025. https://www.hcplive.com/view/dupilumab-improves-small-airway-dysfunction--type-2-asthma

4. Johnson V. Pulmonary Rehabilitation Reduces Type 2 Inflammation in High Inflammation Asthma. Article. HCPLive. December 2, 2025. https://www.hcplive.com/view/pulmonary-rehabilitation-reduces-type-2-inflammation-high-inflammation-asthma

5. Johnson V. Tezepelumab Drastically Reduces OCS Use for Asthma in Open-Label Trial. Article. HCPLive. November 28, 2025. https://www.hcplive.com/view/tezepelumab-drastically-reduces-ocs-use-asthma-open-label-trial

6. Johnson V. Dexpramipexole Oral Add-On for Asthma Significantly Improves Lung Function Over Placebo. Article. HCPLive. September 16, 2025. https://www.hcplive.com/view/dexpramipexole-oral-add-on-asthma-significantly-improves-lung-function-placebo

7. Derman C. Rezpegaldesleukin Shows Strong Phase 2b Results for Atopic Dermatitis, Asthma. Article. HCPLive. November 21, 2025. https://www.hcplive.com/view/rezpegaldesleukin-shows-strong-phase-2b-results-atopic-dermatitis-asthma

8. Criner G, Rogers L, Ho AT. Rewriting Airway Disease With Trait-Based Care: 2025’s Convergence of Asthma and COPD Management. Article. HCPLive. December 1, 2025. https://www.hcplive.com/view/rewriting-airway-disease-with-trait-based-care-convergence-asthma-copd-management

9. Rizzo A, Thurston G. 2025 State of the Air: Dangers of the Air We Breathe with George Thurston, ScD. Video. HCPLive. May 13, 2025. https://www.hcplive.com/view/2025-state-of-the-air-dangers-of-the-air-we-breathe-with-george-thurston-scd

10. El-Hasan A, Rizzo A. After the Smoke: Wildfire Cleanup & Air Quality Concerns with Afif El-Hasan, MD. Video. HCPLive. February 24, 2025. https://www.hcplive.com/view/after-the-smoke-wildfire-cleanup-air-quality-concerns-el-hasan