Insmed has received approval from the EC for Brinsupri (brensocatib 25 mg tablets) to treat non-cystic fibrosis bronchiectasis (NCFB) in patients aged 12 and above with two or more exacerbations in the past year. This is the first approved treatment for NCFB in the European Union (EU).
Approval followed evaluation of data from the Phase III Aspen and Phase II Willow studies published in the New England Journal of Medicine. In the Aspen study, brensocatib 25 mg reduced the annual exacerbation rate by 19.4% versus placebo and significantly prolonged the time to first exacerbation. Patients also experienced reduced decline in lung function at week 52 compared to placebo.
Common adverse reactions reported were hyperkeratosis (5.9%), headache (9.2%), rash (4.1%), dermatitis (4.2%), dry skin (3%) and upper respiratory infections (3.9%).
NCFB is a progressive, chronic lung disease, causing permanent airway widening, which hampers mucus and bacteria clearance, leading to infection and inflammation.
Author summary: Brensocatib’s EC approval marks a first EU option for NCFB, with phase 3 data showing reduced exacerbations and preserved lung function, balanced by manageable adverse effects.
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