Q3 2025 Recap: 7 Pulmonology Updates to Know

Q3 2025 brought a wave of pivotal pulmonology news, marked by first-in-class FDA approvals, promising phase 3 readouts, and other insights from the European Respiratory Society (ERS) meeting. Highlights included the arrival of biologics in COPD care with mepolizumab’s approval for eosinophilic disease, the first disease-modifying therapy for bronchiectasis, and a landmark immunotherapy for recurrent respiratory papillomatosis.

In parallel, advances in interstitial lung disease and asthma expanded therapeutic options, with treprostinil showing functional gains in idiopathic pulmonary fibrosis, albuterol/budesonide extending to mild asthma, and dexpramipexole demonstrating lung function improvements in eosinophilic asthma. Data presented at ERS, including dupilumab analyses linking early lung function improvements to long-term COPD outcomes, underscored the growing role of personalized medicine across respiratory care.

Check out this Q3 recap of pulmonology news for a look back at HCPLive’s coverage of the top pulmonary news and research from the past quarter:

1. The Biologic Era in COPD: What Mepolizumab Approval Means for Exacerbation Control
Joseph Khabbaza, MD, Nikita Desai, MD, and Eric Costanzo, MD, discussed the clinical impact of the FDA approval of mepolizumab for eosinophilic COPD, highlighting its potential to reduce exacerbations and lower corticosteroid dependence in a traditionally treatment-resistant population. Supported by the phase 3 MATINEE trial, mepolizumab marks a shift toward personalized care in COPD, offering a targeted option for the estimated 40% of patients with type 2 inflammation and drawing parallels to the evolution seen in asthma management.

2. FDA Approves First Bronchiectasis Therapy, Brensocatib, for Ages 12 and Up

The FDA approved brensocatib as the first disease-modifying therapy for non-cystic fibrosis bronchiectasis in patients aged 12 and older, based on phase 3 ASPEN trial data showing a 21% reduction in annualized pulmonary exacerbation rates versus placebo. Brensocatib, targeting neutrophil-driven inflammation, also demonstrated modest preservation of FEV1 and a manageable safety profile, representing a potential new standard of care.

3. Zopapogene Imadenovec First Immunotherapy Approved for Recurrent Respiratory Papillomatosis

The FDA approved zopapogene imadenovec-drba (Papzimeos) as the first immunotherapy for recurrent respiratory papillomatosis in adults, offering a non-replicating adenoviral vector–based approach to reduce disease burden. In a pivotal Phase 1/2 trial, 51% of patients achieved complete response and over 85% experienced reduced surgical interventions, with a favorable safety profile dominated by mild-to-moderate injection site reactions and systemic symptoms.

4. Treprostinil Inhalation Significantly Improves FVC in People With Idiopathic Pulmonary FIbrosis

The phase 3 TETON-2 trial of nebulized treprostinil in idiopathic pulmonary fibrosis (IPF) met its primary endpoint, showing a significant improvement in absolute forced vital capacity (FVC) compared with placebo, with a mean difference of 95.6 mL at 52 weeks. Benefits were consistent across subgroups, including those on background antifibrotic therapy, and extended to most secondary outcomes such as quality of life, diffusion capacity, and time to first clinical worsening event. The therapy was well-tolerated with no new safety signals, and United Therapeutics plans to use data from TETON-2 and the ongoing TETON-1 study to support a supplemental FDA application for IPF.

5. 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.

6. Early Lung Function Gains With Dupilumab Linked to Long-Term COPD Outcomes, With Nicola Hanania, MD, MS

Hanania discussed a new post hoc analysis of the phase 3 NOTUS and BOREAS trials presented at the ERS meeting that suggests that early lung function gains with dupilumab in COPD can predict long-term benefits, including fewer exacerbations and better quality of life. The findings highlight the potential of using early objective measures, such as forced expiratory volume, to guide treatment decisions and personalize biologic therapy in COPD.

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

A phase 3 trial has shown that dexpramipexole, an investigational oral therapy, significantly improved lung function in patients with eosinophilic asthma when added to standard treatment. Results from the EXHALE-4 study demonstrated that the 150 mg twice-daily dose achieved statistically significant improvements in pre-bronchodilator FEV1 compared with placebo, with benefits observed as early as Week 4. The therapy also reduced blood eosinophil counts and was well tolerated, with a safety profile consistent with earlier studies.