The European Medicines Agency (EMA) has recommended granting marketing authorisation for Brinsupri (brensocatib) 25 mg tablets in the European Union. The medicine is intended for patients aged 12 and older with non-cystic fibrosis bronchiectasis (NCFB) who have experienced two or more exacerbations in the previous year.
NCFB is a chronic and progressive lung disease that leads to damaged airways, impaired lung function, chronic cough, excessive mucus production and recurrent infections. With an estimated 400,000 to 3 million patients in the EU, and no authorised treatments currently available, the condition represents a major unmet medical need.
Brinsupri works by inhibiting the enzyme DPP1, preventing the activation of neutrophil serine proteases (NSPs), proteins that cause airway damage and sustained inflammation. By blocking this pathway, the medicine reduces harmful inflammatory activity in the lungs.
The CHMP recommendation is based on a large clinical trial involving 1,767 patients, where Brinsupri demonstrated:
• a 19.4% reduction in annual exacerbation rate
• a 14-week delay in time to first exacerbation
• a significantly higher proportion of patients remaining exacerbation-free at 52 weeks
Common side effects include headache, gum inflammation and various skin reactions such as dermatitis, hyperkeratosis, rashes and dry skin.
Brinsupri received support through EMA’s PRIME scheme, highlighting its potential to address a major public health need. The CHMP opinion will now be forwarded to the European Commission for a final decision.
Read the official EMA communication here.
