The European Commission approved Insmed’s BRINSUPRI (brensocatib) on November 18, 2025, granting the first and only EU‑approved therapy for non‑cystic fibrosis bronchiectasis (NCFB) in patients 12 years and older who have had at least two exacerbations in the past year.
The approval was based on data from the Phase 3 ASPEN and Phase 2 WILLOW studies. In ASPEN, patients receiving 25 mg of BRINSUPRI experienced a 19.4 % reduction in annual exacerbation rate, along with measurable improvements in lung function. The safety profile was consistent with earlier trials, with headache, hyperkeratosis, and dermatitis reported as the most common adverse reactions.
The EU market for NCFB is sizable, with roughly 600,000 diagnosed patients and an estimated 2 million potentially undiagnosed individuals. BRINSUPRI’s first‑mover status positions Insmed to capture a significant share of this unmet need, creating a new revenue stream in a previously untapped therapeutic area.
Insmed’s Q3 2025 financial results provide context for the approval. Revenue rose 52 % year‑over‑year to $142.3 million, while the company posted a net loss of $1.75 per share. The company also raised its full‑year 2025 ARIKAYCE revenue guidance to $420 million–$430 million and reported $1.7 billion in cash, cash equivalents, and marketable securities, underscoring the financial foundation for expanding BRINSUPRI’s commercial footprint.
Strategically, the EU approval is a key milestone in Insmed’s plan to transition from a single‑product company to a multi‑product biopharmaceutical leader. The company intends to secure patient access in the EU by early 2026 and is simultaneously preparing launches in the U.K. and Japan, reinforcing its global growth trajectory.
The approval not only validates BRINSUPRI’s clinical efficacy and safety but also signals a broader shift in Insmed’s portfolio strategy, positioning the company to capitalize on a growing market for neutrophil‑mediated respiratory diseases while leveraging its existing pipeline and financial resources.
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