The Commission granted EU marketing authorisation 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 three 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, today’s authorisation responds to an important unmet medical need.
The authorisation is based on a positive scientific assessment from the European Medicines Agency (EMA). Brensocatib is subject to medical prescription and may cause some side effects which are listed in the product information leaflet. It should not be used in pregnancy.
The Commission decision will be available soon at: Union Register of medicinal products.
Source: European Commission | Public Health | Latest updates (https://tinyurl.com/5n7vyhxr)