BRUSSELS/FRANKFURT/PARIS (dpa-AFX) - The European Commission has granted EU marketing authorization for 'brensocatib,' a new active substance for the treatment of chronic progressive lung disease (non-cystic fibrosis bronchiectasis, or NCFB) in patients aged 12 years and older.
The estimated number of patients with NCFB in the EU ranges from 400,000 to 3 million. The disease causes damaged airways and severe pulmonary dysfunction, often leading to chronic cough and airflow obstruction. It is driven by repeated infections and inflammation, and can be triggered by several causes such as respiratory infections, autoimmune diseases, and immunodeficiency disorders.
As there are currently no approved treatments directly addressing this disease, Tuesday's authorization responds to an important unmet medical need.
The authorization is based on a positive scientific assessment from the European Medicines Agency. The European Commission has warned that Brensocatib is subject to medical prescription and may cause some side effects which are listed in the product information leaflet.
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