FDA Approves First Treatment for Chronic Inflammatory Lung Condition

The FDA has approved Brinsupri (brensocatib) to treat non-cystic fibrosis bronchiectasis (NCFB), a chronic inflammatory lung condition, in patients ages 12 years and older.

NCFB is a progressive respiratory condition. Patients experience frequent cough, shortness of breath, and recurrent infections due to the damage the disease causes to the lungs. Unlike other respiratory diseases that are characterized by airway narrowing, bronchiectasis causes airways to permanently widen, making it harder to clear mucus and bacteria, leading to persistent inflammation and infection. About 500,000 people in the United States are diagnosed with the condition.

Doreen Addrizzo-Harris, M.D.

“For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations,” Doreen Addrizzo-Harris, M.D., FCCP, said in a news release. She is the Fiona and Stanley Druckenmiller Professor of Pulmonary, Critical Care, and Sleep Medicine at NYU Grossman School of Medicine and Director of the NYU Langone Health Bronchiectasis.

Developed by Insmed, Brinsupri is an oral, once-daily treatment that is offered in 10 mg and 25 mg tablets and is the first treatment for non-cystic fibrosis bronchiectasis. Brinsupri is a first-in-class dipeptidyl peptidase 1 (DPP1) inhibitor designed to inhibit the activation of enzymes (neutrophil serine proteases) in neutrophils that are key drivers of chronic airway inflammation in NCFB.

Brinsupri is now available through a specialty pharmacy network with an annual list price of $88,000 for either dosage form, according to an Insmed spokesperson. The company said it is currently working with payers for coverage of Brinsupri, and they expect that most payers will require prior authorization according to the inclusion criteria from the phase 3 ASPEN study. Insmed offers financial assistance programs for eligible patients, as well as the inLighten patient support program.

In an investor presentation, company officials indicated that physicians in a survey said that there is a high unmet need in non-cystic fibrosis bronchiectasis, and 90% would likely prescribe Brinsupri for patients with two or more exacerbations.

The approval of Brinsupri is based on data from the phase 3 ASPEN and phase 2 WILLOW studies, which were both published in the New England Journal of Medicine. In ASPEN, patients taking Brinsupri 10 mg or 25 mg had a 21.1% and 19.4% reduction in the annual rate of exacerbations compared with placebo. Both dosage strengths of Brinsupri also met several secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period.

Patients who received Brinsupri 25 mg experienced statistically significant less decline in lung function, as measured by forced expiratory volume in one second (FEV₁) after using a bronchodilator, at week 52.

Brinsupri’s label has a warning about the risk of skin reactions and the risk for gum and tooth problems. The most common side effects include upper respiratory tract infections, headache, rash, dry skin, hyperkeratosis (skin thickening), and hypertension. Less common side effects include an increase in liver function blood tests, alopecia (hair loss), and certain skin cancers.

Insmed is also conducting trials of Brinsupri in other conditions, including a phase 2b trial as a treatment for patients with chronic rhinosinusitis without nasal polyps (CRSsNP) and in a phase 2b trial for hidradenitis suppurativa (HS), an inflammatory skin condition that causes painful bumps. Topline data in the trial for the CRSsNP indication is expected by the end of 2025. In the trial for HS, the company plans to conduct an interim futility analysis on the first 100 patients enrolled in the first quarter of 2026.