The Front Room — a clinical regulatory commons
RSS
← Back to The Docket
AUG 12 2025
APPROVED · 413 DAYS AGO

Insmed — Brinsupri (brensocatib) $INSM

for non-cystic fibrosis bronchiectasis

NDA · Priority Review · Breakthrough · Orphan

FDA approved Brinsupri as the first targeted therapy for non-CF bronchiectasis, addressing a population of ~350,000 US patients previously managed with macrolide antibiotics and supportive care.

About

Bronchiectasis is a lung disease in which the airways become permanently widened and damaged, causing chronic cough with mucus, shortness of breath, chest pain, and frequent lung infections. Brinsupri is an oral medicine that blocks DPP-1, an enzyme immune cells use to switch on the destructive proteins that drive airway inflammation. By calming that inflammatory cascade, it may reduce the flare-ups that repeatedly damage already-weakened airways.

Pivotal trial

ASPEN Phase 3 completed NCT04594369

The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.

Source: ClinicalTrials.gov

Also in development