For the first time, patients in the EU with non-cystic fibrosis bronchiectasis (NCFB) have an approved treatment, after the European Commission authorized ‘Brensocatib‘. The drug is approved for use in adult and adolescent patients aged 12 years and older.
The decision addresses a major unmet medical need, as no other medicines are currently authorized in the EU for this condition.
The authorization follows a positive scientific assessment from the European Medicines Agency (EMA). Brensocatib will be available by prescription only, with health authorities warning that it may cause side effects and should not be used during pregnancy.
The treatment was approved for medical use in the United States in August, offering further evidence of its safety and efficacy.
NCFB is a chronic, progressive disease that damages the airways, causing severe lung dysfunction.
It is characterized by chronic cough and airflow obstruction, driven by repeated infections and inflammation, and affects an estimated 400,000 to three million people in the EU.