Insmed’s Brinsupri approved in EU for non-cystic fibrosis bronchiectasis

Insmed (INSM) Incorporated announced that the European Commission has approved BRINSUPR for the treatment of non-cystic fibrosis bronchiectasis in patients 12 years of age and older with two or more exacerbations in the prior 12 months. BRINSUPRI is a first-in-class therapy, offering the first and only approved treatment indicated for NCFB in the European Union. BRINSUPRI was reviewed under accelerated assessment by the EMA as it is deemed to be of major interest for public health. This approval is based on a comprehensive scientific evaluation of the marketing authorization application, including data from the Phase 3 ASPEN and Phase 2 WILLOW studies, which were both published in the New England Journal of Medicine. In ASPEN, patients taking BRINSUPRI 25 mg had a 19.4% reduction in annual rate of exacerbations, as compared to placebo. BRINSUPRI 25 mg also met several exacerbation-related secondary endpoints, including significantly prolonging the time to first exacerbation and significantly increasing the proportion of patients remaining exacerbation-free over the treatment period. Patients who received BRINSUPRI 25 mg experienced statistically significant less decline in lung function, as measured by forced expiratory volume in one second after using a bronchodilator, at week 52. The safety of BRINSUPRI was also evaluated in both studies. The most frequently reported adverse reactions are headache (9.2%), hyperkeratosis (5.9%), dermatitis (4.2%), rash (4.1%), upper respiratory tract infections (3.9%), and dry skin (3.0%).