The European Medicines Agency (EMA) has recommended approval of brensocatib (Brinsupri) for non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older, marking the first such approval in Europe for this condition.

This recommendation follows positive results from Phase 3 ASPEN and Phase 2 WILLOW clinical trials, which demonstrated that brensocatib reduced exacerbations and delayed their onset in patients aged 12 and older.

Brensocatib works by inhibiting the DPP1 enzyme, which reduces neutrophil activation; excessive neutrophil activity damages airway walls, increases mucus, and sustains inflammation in NCFB.

Non-cystic fibrosis bronchiectasis is a serious, progressive lung disease affecting over 1.2 million people globally, causing symptoms like chronic cough, sputum production, and recurrent infections, with no targeted therapies available outside the U.S.

In the U.S., brensocatib is already approved for NCFB in adults and children aged 12 and older, with ongoing safety monitoring for side effects such as skin issues, gum reactions, and liver enzyme elevations.

The EMA's recommendation was supported by its Priority Medicines (PRIME) designation and accelerated review process, highlighting its potential public health impact and therapeutic innovation.

The European Commission will review the EMA's opinion, with a final decision expected within a few months, and detailed usage instructions will be published in all EU languages.

Use of brensocatib during pregnancy is not recommended due to animal studies indicating embryo-fetal toxicity, and the medication will be available as 25 mg film-coated tablets.

Adverse events were similar across treatment groups, though brensocatib was associated with a higher incidence of hyperkeratosis; common side effects include headache, gum disease, dermatitis, rash, respiratory infections, and dry skin.

The approval is based on clinical benefits demonstrated in published studies, showing that 48.5% of patients remained exacerbation-free after 52 weeks of treatment.

Brensocatib's approval could significantly change the treatment landscape for NCFB by addressing an unmet medical need, with ongoing studies exploring its role in other neutrophil-mediated diseases.

Detailed usage instructions and further information will be available on the EMA’s website once the European Commission grants final approval.