On Oct 17 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion recommending approval of Insmed’s brensocatib (BRINSUPRI) for the treatment of non‑cystic fibrosis bronchiectasis (NCFB). The recommendation follows a review of Phase 3 ASPEN and Phase 2 WILLOW data and is the first step toward EU market authorization for the 25‑mg tablet formulation.
If approved, BRINSUPRI would become the first and only EU‑approved therapy for NCFB, a chronic lung disease affecting an estimated 600,000 patients in the EU5 alone. Insmed estimates the EU market could reach several hundred million euros in annual sales once launch occurs, providing a significant new revenue stream beyond the United States where the drug has already received FDA approval.
The CHMP’s accelerated assessment underscores the drug’s clinical benefit and the unmet need in bronchiectasis. Approval would expand Insmed’s commercial footprint in Europe, potentially generating substantial sales and reinforcing the company’s position as a leader in rare pulmonary diseases.
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