The FDA has approved Brinsupri (brensocatib) for adults and adolescents aged 12 years and older with non-cystic fibrosis bronchiectasis. 

Developed by Insmed Incorporated, brensocatib is a once-daily, first-in-class oral dipeptidyl peptidase 1 inhibitor that targets neutrophilic inflammation—a central driver of disease pathophysiology. NCFB affects an estimated 500,000 patients in the US and is characterized by permanent airway widening, impaired mucus clearance, and bacterial colonization, which contribute to persistent inflammation, infection, and frequent exacerbations that can progressively damage lung function.

In the phase 3 ASPEN and phase 2 WILLOW trials, brensocatib reduced annualized exacerbation rates in patients with non-cystic fibrosis bronchiectasis by more than 21% compared with placebo, leading to FDA approval as the first therapy for this condition.

In ASPEN, patients randomized to brensocatib 10 mg and 25 mg experienced a 21.1% and 19.4% reduction, respectively, in annualized exacerbation rates compared with placebo. Both doses significantly prolonged time to first exacerbation and increased the proportion of patients remaining exacerbation-free over 52 weeks. The 25 mg dose was associated with less decline in post-bronchodilator forced expiratory volume in one second at week 52.

The most common adverse reactions, reported in at least 2% of patients in the ASPEN trial, included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension. Dermatologic and dental adverse events, including gingival and periodontal reactions, were observed and warrant monitoring. Use of live attenuated vaccines should be avoided during treatment. Safety findings in the WILLOW trial were consistent with ASPEN, with a higher incidence of gingival and periodontal events in WILLOW.

Brinsupri is now available in the US through a specialty pharmacy network. Regulatory submissions have been accepted in Europe and the UK, with a Japan filing planned for 2025. Commercial launches in additional regions are anticipated in 2026, pending regulatory approval.

Source: Insmed