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NEWS

Insmed Reports the EC’s Approval of Brinsupri (Brensocatib) for Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The EC has approved Brinsupri (25mg) for treating NCFB pts (≥12yrs.), with ≥2 exacerbations in the prior 12mos. under EMA'saccelerated assessment pathway; Application is under PMDA & MHRA review, & Insmed is planning to work with EU authorities to enable patient access starting in early 2026 Approval was based on extensive clinical data, incl. P-III (ASPEN)…
November 19, 2025

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INSIGHTS+

EMA Marketing Authorization of New Drugs in October 2025  

Shots:  Innovation in drug development continues to redefine the future of healthcare, fueling bold scientific partnerships and transforming how diseases are understood, managed, and treated across every therapeutic frontier  In October, the EMA issued positive CHMP opinions for two significant therapies: Sanofi’s Wayrilz (rilzabrutinib) for adults with immune thrombocytopenia, and Insmed’s Brinsupri (brensocatib) for the…
November 18, 2025

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NEWS

Insmed’s Brinsupri (Brensocatib) Receives the CHMP’s Positive Opinion to Treat Non-Cystic Fibrosis Bronchiectasis (NCFB)

Shots: The CHMP has recommended Brinsupri (Brensocatib) for treating NCFB pts (≥12yrs.) with two or more exacerbations in the prior 12 mos. Opinion was based on P-III (ASPEN) trial (n=1721) & P-II (WILLOW) trial (n=256) assessing Brinsupri (10 or 25mg, PO) vs PBO in NCFB pts for 52 & 24wks., respectively, with WILLOW enrolling pts who had…
October 21, 2025

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