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CSL’s ANDEMBRY® Gains FDA Nod, Ushering New Era for Hereditary Angioedema Care
8:46am on Tuesday 17th of June, 2025 AEST
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Healthcare
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CSL’s ANDEMBRY® Gains FDA Nod, Ushering New Era for Hereditary Angioedema Care
8:46am on Tuesday 17th of June, 2025 AEST
Key Points
FDA approves CSL’s ANDEMBRY® for hereditary angioedema prevention
First treatment targeting factor XIIa with once-monthly autoinjector dosing
Phase 3 VANGUARD trial shows over 99% median reduction in attacks
Immediate US launch planned, following approvals in multiple global markets
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