The FDA has approved Insmed’s Brinsupri (brensocatib), delivering two firsts in a single regulatory decision: the first therapy for non-cystic fibrosis bronchiectasis (NCFB) and the first marketed dipeptidyl peptidase 1 (DPP1) inhibitor.
NCFB is a chronic, progressive lung condition in which the airways become permanently damaged, leading to persistent cough, excessive mucus production, and recurrent infections. Affecting approximately 350,000 to 500,000 US adults, NCFB has primarily been managed using antibiotics, airway clearance procedures, and supportive care, with no approved disease-specific treatments.
Brinsupri, an oral therapy available in 10 mg and 25 mg tablets, will be priced at $88,000 per year. The drug’s approval is supported by data from the Phase 3 ASPEN and Phase 2 WILLOW trials, which showed significant reductions in exacerbation rates, 21 percent for the 10mg dose and 19 percent for the 25mg dose, alongside extended time to first flare-up and higher rates of patients remaining exacerbation-free for a year.
"For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations,” said Doreen Addrizzo-Harris, a pulmonary and critical care physician at NYU Langone Pulmonary & Critical Care Associates. “Based on the strength of the data and the impact we've seen in patients, I believe this could become the new standard in non-cystic fibrosis bronchiectasis care.”
From antibiotics to targeted inflammation control
Brinsupri directly targets the inflammatory processes driving the disease. The once-daily oral therapy is a reversible inhibitor of DPP1, an enzyme that activates neutrophil serine proteases (NSPs) inside white blood cells.
Under healthy circumstances, NSPs help fight infection and mediate inflammation. In NCFB, however, excessive activation leads to chronic airway inflammation, tissue destruction, and a cycle of exacerbations that accelerate disease progression. By blocking DPP1, Brinsupri reduces NSP activity, breaking this harmful cycle.
“Brinsupri represents the first on-label non-antibiotic, anti-inflammatory treatment option that offers a more targeted action and possibly shift away from use of antibiotics in this disease space,” commented Pharma Analyst Vinie Varkey to Pharma Live.
Potential beyond bronchiectasis
Insmed is moving quickly to globalize Brinsupri, with marketing applications already submitted to Europe, Japan, and the UK, targeting launches in 2026. According to an investor presentation, the company estimates the drug could generate $5 billion in annual peak sales for NCFB alone.
But Brinsupri’s mechanism of action could open the door to much wider use in respiratory and inflammatory disease. Excess neutrophil-driven inflammation plays a key role in conditions such as chronic obstructive pulmonary disease, chronic rhinosinusitis without nasal polyps (CRSsNP), and hidradenitis suppurativa (HS). Insmed is currently exploring the use of Brinsupri against both CRSsNP and HS in early-stage trials.
As the first DPP1 inhibitor to market, Brinsupri could open the door to a new class of targeted anti-inflammatory therapies for a range of diseases with shared underlying pathways.
