Insmed has received the US Food and Drug Administration (FDA) approval for Brinsupri (brensocatib) to treat non-cystic fibrosis bronchiectasis (NCFB).
The oral medication, available in 10mg and 25mg dosages, is indicated for adults and children with NCFB, aged 12 years and above.
Brinsupri is a dipeptidyl peptidase 1 (DPP1)-inhibitor, targeting neutrophilic inflammation, which plays a key role in the chronic airway inflammation related to NCFB.
As the first FDA-approved treatment for NCFB, Brinsupri offers a new option to manage the progressive lung disease, which can result in significant lung damage over time.
Insmed chief medical officer Martina Flammer said: “The FDA approval of the first-ever treatment for non-cystic fibrosis bronchiectasis is a historic milestone for patients and for Insmed.
“By keeping patients at the centre of everything we do, we have once again delivered a first-in-class medicine for a disease with no prior approved treatments.
“This is an incredible achievement in medicine. We’re deeply grateful to the patients, providers, and advocates who made this possible, this is just the beginning of what we can accomplish together for this community.”
The FDA’s decision is based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies, both published in the New England Journal of Medicine.
In the ASPEN trial, Brinsupri 10mg and 25mg dosages reduced annual exacerbation rates by 21.1% and 19.4%, respectively, compared to a placebo group.
The two dosage strengths also achieved notable improvements in secondary endpoints related to exacerbations throughout the treatment period.
The secondary endpoints include a longer time to the first exacerbation and a higher proportion of patients remaining free from exacerbations.
Patients receiving the 25mg dosage showed a statistically significant reduction in lung function decline, measured by forced expiratory volume in one second (FEV₁) after bronchodilator use at week 52.
The most common adverse reactions included upper respiratory tract infection, headache, rash, dry skin, hyperkeratosis, and hypertension.
The WILLOW study reported a higher incidence of gingival and periodontal reactions compared to the ASPEN trial.
ASPEN investigator Doreen Addrizzo-Harris said: “This FDA approval represents a potential paradigm shift in how we approach non-cystic fibrosis bronchiectasis.
“For the first time, we have a treatment that directly targets neutrophilic inflammation and addresses a root cause of bronchiectasis exacerbations.
“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.”
Brensocatib, the active ingredient in Brinsupri, is also being explored for its potential in treating other neutrophil-mediated diseases.
Regulatory applications for brensocatib have been accepted by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA). Insmed plans to file an application for the drug’s approval in Japan this year.
The US drugmaker is planning to commercially launch brensocatib in 2026, pending regulatory approval in each region.
