
European Commission Authorizes First Treatment For Serious Chronic Lung Disease

The European Commission has authorized 'brensocatib' for treating non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and older. This addresses a significant unmet medical need, as NCFB affects 400,000 to 3 million people in the EU. The authorization follows a positive assessment by the European Medicines Agency, though the drug requires a prescription and may have side effects.
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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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