Insmed Incorporated (INSM) announced that the European Commission has approved BRINSUPRI for the treatment of non-cystic fibrosis bronchiectasis in patients aged 12 and older with recurrent exacerbations.
Non-cystic fibrosis bronchiectasis (NCFB) affects an estimated 600,000 diagnosed patients in the EU, with up to two million more potentially undiagnosed. The disease is marked by persistent airway inflammation, with recurrent infections that often lead to progressive lung damage.
BRINSUPRI is a first-in-class, oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), designed to block activation of neutrophil serine proteases that drive chronic airway inflammation in NCFB. Administered once daily, BRINSUPRI represents the first and only approved therapy for this debilitating lung disease in the European Union.
BRINSUPRI was reviewed under EMA's accelerated assessment pathway, as it is considered of major interest for public health.
The approval was based on results from the Phase 3 ASPEN trial and the Phase 2 WILLOW study.
In the ASPEN trial, patients treated with BRINSUPRI 25 mg achieved a 19.4% reduction in the annual rate of exacerbations compared to placebo. The therapy also significantly prolonged the time to first exacerbation and increased the proportion of patients who remained exacerbation-free during the study period.
In the WILLOW trial, BRINSUPRI similarly prolonged the time to first pulmonary exacerbation compared to placebo, further supporting its efficacy in reducing flare frequency.
Safety data across both studies indicated the regimen was generally manageable.
Data from the ASPEN study will be presented at the upcoming scientific meetings, providing further visibility into the clinical impact of this therapy. Regulatory applications are also under review in the U.K. and Japan. Insmed plans to work with EU authorities to secure patient access beginning in early 2026.
This approval marks a major milestone for Insmed, positioning BRINSUPRI as the first treatment option for NCFB.
The drug was approved by the FDA on August 12, 2025, as the first and only treatment for non-cystic fibrosis bronchiectasis in patients 12 years and older.
INSM has traded in the range of $60.40 to $203.65 over the past year. The stock closed yesterday's trading at $201.62, up 2.14%.
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