Pulmonology Month in Review: February 2025

February in pulmonology saw new treatments and regulatory developments shaping the respiratory care landscape. A survey highlighted the need for better integration of inhaled triple therapy in asthma management, as many clinicians hesitated to adopt it despite its potential to reduce exacerbations. Meanwhile, a first-in-class DPP1 inhibitor for non-cystic fibrosis bronchiectasis received Priority Review from the US Food and Drug Administration (FDA).

The regulatory agency also accepted a Biologics License Application (BLA) for a novel treatment for recurrent respiratory papillomatosis, a rare disease with no approved pharmacologic options. An investigational oral, preferential inhibitor of phosphodiesterase 4B (PDE4B) met its primary endpoint in the Phase 3 FIBRONEER-ILD trial, paving the way for a forthcoming New Drug Application (NDA) submission.

Results from the Phase 4 VESTIGE study suggested that dupilumab may also improve small airway dysfunction in type 2 asthma, while dupilumab demonstrated a meaningful reduction in COPD exacerbations in a Phase 3 analysis. Beyond clinical developments, environmental concerns took center stage in February’s edition of Lungcast, where experts discussed the rising impact of wildfires on air quality and respiratory health.

Here’s what happened in February:

Inhaled Triple Therapy Needs Better Integration into Asthma Care

A new survey found that inhaled triple therapy (ITT) was not widely used by clinicians due to uncertainty in treatment regimen implementation, despite its benefit for decreasing exacerbation rate. Only 36% of specialists considered ITT a relevant therapeutic option, while 62% considered it as a second option after reaching a high dose of ICS-LABA, and 89% agreed that optimization of inhaled therapy should be attempted before the use of biological drugs.

Brensocatib, Potential First Treatment for Non-CF Bronchiectasis, Gets Priority Review

The FDA has granted Priority Review to Insmed’s NDA for brensocatib, a dipeptidyl peptidase 1 (DPP1) inhibitor that could be the first treatment option for patients with non-cystic fibrosis bronchiectasis. Targeting a PDUFA date of August 12, 2025, the NDA submission was based on positive data from the landmark Phase 3 ASPEN study, in which brensocatib significantly reduced the annualized rate of pulmonary exacerbations compared with placebo.

Dupilumab Reduced COPD Exacerbations Compared to Placebo

Adding dupilumab to standard triple therapy reduced the annualized moderate or severe exacerbations of chronic obstructive pulmonary disease (COPD) in a pooled analysis of Phase 3 findings. Moderate or severe exacerbations were reported in 36.0% of the dupilumab cohort and 42.1% of the placebo group—the dupilumab cohort also had a lower annualized exacerbation rate and longer time to first severe exacerbation than the placebo group.

Nerandomilast Meets Primary Endpoint in Improving FVC in Progressive Pulmonary Fibrosis

Nerandomilast met the primary endpoint in the Phase 3 FIBRONEER-ILD trial, significantly improving forced vital capacity (FVC) among individuals with progressive pulmonary fibrosis (PPF), compared with placebo. Based on these findings, Boehringer Ingelheim announced plans to submit an NDA for nerandomilast to the FDA.

FDA Accepts BLA for PRGN-2012 for Recurrent Respiratory Papillomatosis

The FDA accepted Precigen, Inc.’s BLA for PRGN-2012 (zopapogene imadenovec), an investigational gene therapy targeted for adults with recurrent respiratory papillomatosis (RRP), a rare disease that requires repeated surgeries with no current therapeutic alternative. A Prescription Drug User Fee Act (PDUFA) action date of August 27, 2025, was set, with no plans to hold an advisory committee meeting.

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.

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

In the latest episode of our flagship pulmonology podcast series, Lungcast, host Albert Rizzo, MD, chief medical officer of the American Lung Association (ALA), discussed the increase in wildfire incidence and its status as an escalating health concern, as poor air quality from the fires can be greatly impactful on a patient’s health. Rizzo discussed this topic with Afif El-Hasan, MD, a pediatrician at Kaiser Permanente and a Board Director and Chair of the Public Policy Committee at the ALA.