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AUG 12 2025
APPROVED · 353 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 where parts of the airways become permanently enlarged and damaged, leading to a chronic cough with mucus, shortness of breath, and frequent lung infections. Brinsupri (brensocatib) is an oral drug that blocks an enzyme called DPP-1, which is involved in activating certain inflammatory cells in the lungs. By inhibiting this enzyme, the drug aims to reduce the inflammation that drives damaging flare-ups, potentially leading to fewer lung infections for patients.

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