The European Medicines Agency (EMA) has recommended approval of Brinsupri (brensocatib) 25 mg tablets for patients aged 12 and older with non-cystic fibrosis bronchiectasis (NCFB) who have experienced two or more exacerbations in the past year. If authorised, this would be the first approved medicine in the EU for this chronic lung disease.
NCFB is a serious, long-term condition that damages the airways and leads to chronic cough, airway obstruction and abnormal mucus production. It is typically caused by repeated infections and inflammation and can develop after respiratory infections, autoimmune diseases or immunodeficiency disorders. Within the EU, the number of people affected is estimated to be between 400,000 and three million.
People living with NCFB often experience one to four flare-ups (exacerbations) per year, which worsen lung function, increase the risk of death and significantly reduce quality of life. With no approved treatments currently available, patients rely on airway clearance techniques, antibiotics and anti-inflammatory medicines to manage symptoms.
How Brinsupri works
Brinsupri contains brensocatib, which blocks dipeptidyl peptidase 1 (DPP1)—an enzyme that activates neutrophils, a type of white blood cell. In NCFB, neutrophils become overly active and release damaging enzymes known as neutrophil serine proteases (NSPs). These contribute to airway damage, excess mucus and ongoing inflammation. By inhibiting DPP1, Brinsupri helps reduce the harmful effects of NSPs in the lungs.
Fast-track review for unmet medical need
Brinsupri received support through EMA’s PRIority MEdicines (PRIME) programme, which fast-tracks development of promising treatments for unmet medical needs. The EMA’s Committee for Medicinal Products for Human Use (CHMP) also reviewed the application on an accelerated timetable, recognising its potential public health impact.
Clinical results
EMA’s recommendation is based on a randomised, double-blind, placebo-controlled trial involving 1,767 patients (including both 10 mg and 25 mg dose groups). Key findings for the 25 mg dose include:
- 19.4% reduction in the annual rate of pulmonary exacerbations
- 14-week delay in the median time to first exacerbation
- Significantly more patients remained exacerbation-free at week 52 compared with placebo
The most commonly reported side effects were:
- Headache
- Inflammation of the gums (gingival and periodontal disease)
- Skin reactions such as hyperkeratosis (thickened skin), dermatitis, rash and dry skin
Next steps
This CHMP opinion is an important step toward EU-wide approval. The recommendation will now go to the European Commission, which will make the final decision on marketing authorisation. If approved, each EU Member State will then determine pricing and reimbursement according to national healthcare policies.
Notes
- Total randomised population: 1,767 patients (10 mg and 25 mg groups)
- Applicant: Insmed Netherlands B.V.
- PRIME eligibility granted: 27 February 2020
22.10.2025.
