UK MHRA Approves First-Ever Treatment for Non-Cystic Fibrosis Bronchiectasis
Key Insights
The UK MHRA has granted marketing authorization for brensocatib (Brinsupri (search)), marking the first medicine specifically licensed to treat non-cystic fibrosis bronchiectasis in the UK.
The treatment targets dipeptidyl peptidase 1 (search) protein to prevent lung inflammation and flare-ups in patients aged 12 and older who have experienced two or more symptom exacerbations in the past year.
Brensocatib is administered as a once-daily oral tablet, with common side effects including respiratory infections, gastrointestinal issues, and skin-related reactions.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorization for brensocatib (Brinsupri (search)), marking a significant milestone as the first medicine specifically licensed to treat non-cystic fibrosis bronchiectasis (NCFB) in the United Kingdom. The approval, granted on February 20, 2026, to Insmed Netherlands B.V., covers patients aged 12 years and older who have experienced two or more flare-ups or worsening of symptoms in the past 12 months.
Addressing an Unmet Medical Need
Non-cystic fibrosis bronchiectasis is a chronic, long-term condition characterized by damaged airways in the lungs, resulting in persistent cough with mucus production. While the condition can affect individuals of any age, it is more commonly observed in older adults. Until now, patients with NCFB have lacked access to treatments specifically designed for their condition.
"This is the first medicine licensed in the UK that specifically treats patients living with non-cystic fibrosis bronchiectasis," said Julian Beach, MHRA Executive Director for Healthcare Quality and Access. He emphasized that "the MHRA will keep the safety and effectiveness of brensocatib under close review."
Mechanism of Action and Administration
Brensocatib operates through a targeted approach, blocking the activity of dipeptidyl peptidase 1 (search) (DPP1 (search)), a protein involved in the inflammatory process within the lungs. By inhibiting this protein, the medicine aims to prevent flare-ups and may improve symptoms associated with NCFB.
The treatment is administered as an oral tablet taken once daily, offering patients a convenient dosing regimen for long-term management of their condition.
Safety Profile
Clinical data reveal that the most common side effects associated with brensocatib include nose and throat infection, diarrhea and vomiting, headache, problems affecting the gums, small areas of skin thickening (hyperkeratosis), rash, dryness and inflammation of the skin (dermatitis), and hair loss (alopecia).
A comprehensive list of side effects will be available in the Patient Information Leaflet and the Summary of Product Characteristics, both scheduled for publication on the MHRA website within seven days of approval. Patients experiencing suspected side effects are encouraged to consult their healthcare providers and report through the Yellow Card scheme via the MHRA website or mobile application.