www.ema.europa.eu
EMA has recommended granting a marketing authorisation in the European Union (EU) for Brinsupri (brensocatib) 25 mg tablets, for the treatment of non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 years and older who have had two or more exacerbations (flare-ups) in the prior 12 months.
NCFB is a chronic, progressive lung disease resulting in damaged airways and severe pulmonary dysfunction, often leading to chronic cough and airflow obstruction due to abnormal mucus production. It is driven by repeated infections and inflammation, and can be triggered by several causes, including respiratory infections, autoimmune diseases (when the body’s own defence system attacks normal tissue) and immunodeficiency disorders (when body defences are reduced from birth). The estimated number of patients with NCFB in the EU is between 400,000 and three million.
Patients typically experience between one and four exacerbations per year. Exacerbations are associated with a progressive…