Brinsupri

Opinion

EMA has issued an opinion on this medicine

Brensocatib

Overview

On 16 October 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Brinsupri, intended for the treatment of non-cystic fibrosis bronchiectasis in patients 12 years of age and older.

Brinsupri was reviewed under EMA’s accelerated assessment programme.

Brinsupri will be available as 25 mg film-coated tablets. The active substance in Brinsurpi, brensocatib, is a competitive, reversible inhibitor of dipeptidyl peptidase 1 (DPP1). Brensocatib reduces the activity of neutrophil serine proteases (NSPs) involved in the pathogenesis of bronchiectasis, including neutrophil elastase, cathepsin G and proteinase 3.

The full indication for Brinsupri is:

Brinsupri is indicated for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients 12 years of age and older with two or more exacerbations in the prior 12 months.

The main evidence of efficacy of Brinsupri was based on a Phase III randomised, double-blind, placebo controlled, clinical trial (ASPEN) involving 1,721 patients aged 12 years and older. At 52 weeks, the annualised rate of exacerbations was 1.04 with brensocatib 25 mg compared with 1.29 with placebo; the rate ratio was 0.81 (95% CI [0.69–0.94]), demonstrating a statistically significant reduction compared with placebo.

The most commonly reported adverse reactions were headache, hyperkeratosis, gingival and periodontal diseases, dermatitis, rash, upper respiratory tract infections, and dry skin. Use during pregnancy is not recommended; animal studies have shown reproductive (embryo-foetal) toxicity.

Detailed recommendations for the use of this product are described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Brinsupri

Adopted Reference Number: EMA/CHMP/310418/2025

Product details

• Name of medicine:
  Brinsupri
• Active substance:
  Brensocatib monohydrate
• International non-proprietary name (INN) or common name:
  Brensocatib
• Therapeutic area (MeSH):
  • Bronchiectasis
  • Lung Diseases
• Anatomical therapeutic chemical (ATC) code:
  R03
• EMA product number:
  EMEA/H/C/005820
• PRIME: priority medicine:

  This medicine was granted entry to the EMA Priority Medicines (PRIME) scheme during its development. PRIME is a scheme launched by EMA to enhance support for the development of medicines that target an unmet medical need. This voluntary scheme is based on enhanced interaction and early dialogue with developers of promising medicines, to optimise development plans and speed up evaluation so these medicines can reach patients earlier. For more information, see PRIME: priority medicines.

• Marketing authorisation applicant:
  Insmed Netherlands B.V.
• Opinion adopted:
  16/10/2025
• Opinion status:
  Positive