FDA grants priority review to Insmed's brensocatib NDA for bronchiectasis; PDUFA Aug 12, 2025

INSMED Inc

FDA accepted NDA with Priority Review; target action date August 12, 2025 under PDUFA.
Brensocatib would be first approved treatment for bronchiectasis and first DPP1 inhibitor if approved.
NDA based on Phase 3 ASPEN study meeting primary endpoint of reduced annualized pulmonary exacerbation rate.
Both 10 mg and 25 mg doses also met key secondary endpoints including time to first exacerbation.
Insmed plans EU, UK, Japan submissions in 2025; commercial launches anticipated in 2026, pending approvals.

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