Photo by Dursun Aydemir
BRUSSELS
The European Commission granted marketing authorization Tuesday for the first treatment targeting a serious chronic lung disease known as non-cystic fibrosis bronchiectasis (NCFB).
The approved drug, "brensocatib," is authorized to treat adult and adolescent patients aged 12 years and older, the European Commission said in a statement.
The decision addresses an "important unmet medical need," as there are no other approved medicines in the EU that address the disease.
NCFB is a chronic, progressive condition that damages the airways, leading to severe lung dysfunction. It is characterized by a chronic cough and airflow obstruction, driven by repeated infections and inflammation.
The disease is estimated to affect between 400,000 and three million people in the EU.
The authorization follows a positive scientific assessment from the European Medicines Agency (EMA).
Brensocatib will be available by prescription only. Health authorities noted that the treatment may cause side effects, detailed in the product information, and should not be used during pregnancy.
US regulators approved brensocatib for medical use in August.
