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Redefining Bronchiectasis Care With Brensocatib FDA Approval, With James Chalmers, MBChB, PhD
In August 2025, the US Food and Drug Administration (FDA) approved brensocatib, marking the first-ever approved therapy for non–cystic fibrosis bronchiectasis. This milestone comes after decades in which patients with the condition, characterized by persistent airway inflammation, recurrent infections, and progressive lung damage, had no targeted treatment options. The approval was based on the phase 3 ASPEN trial, the largest study ever conducted in bronchiectasis, enrolling 1,721 patients worldwide.
Brensocatib is an oral, selective, and reversible inhibitor of dipeptidyl peptidase-1 (DPP-1), an enzyme that regulates neutrophil activity. By targeting neutrophils, which are long recognized as central drivers of the inflammatory cascade in bronchiectasis, the drug represents a new mechanism in respiratory medicine.
HCPLive spoke with James Chalmers, MBChB, PhD, professor of respiratory research at the University of Dundee and investigator in the ASPEN trial, to learn more about the significance of the approval and the data supporting it. He discussed its impact on management strategies, and which patient populations stand to benefit most. He also touched on how brensocatib is set to reshape care for bronchiectasis and what its approval means for both clinicians and patients moving forward.
He stressed that ASPEN, both 10 mg and 25 mg doses of brensocatib reduced exacerbations by 20% compared with placebo, with the higher dose also slowing lung function decline by 38 mL over 12 months. These findings not only demonstrate clinical benefit but also validate neutrophil-driven inflammation as a therapeutic target in bronchiectasis.
Importantly, the trial included nearly all subtypes of the disease, with broad consistency of effect across age, sex, etiology, and comorbidities. Only patients with cystic fibrosis, active non-tuberculous mycobacterial infection, allergic bronchopulmonary aspergillosis, or primary immune deficiencies were excluded, leaving the evidence highly generalizable to most individuals living with bronchiectasis.
Chalmers' disclosures include AstraZeneca, Boehringer Ingelheim, Genentech, Gilead, Grifols Biologicals, Insmed, Novartis, and Zambon.
