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CSL Receives the US FDA Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots:  The US FDA has approved Andembry (garadacimab-gxii) for HAE pts (≥12yrs); commercially available before Jun 2025 endApproval was based on P-III (VANGUARD) trial assessing Andembry (n=39) vs PBO (n=25) for 6mos., which showed 62% pts remained attack-free, with reduction in overall HAE attacks by >99% median & 89.2% mean, as well as attacks requiring…

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GSK Reports Health Canada’s NDS Acceptance of Depemokimab for Asthma with Type 2 Inflammation and CRSwNP

Shots:Health Canada has accepted NDS of depemokimab as an adjunctive therapy for asthma pts (≥12yrs.) with type 2 inflammation marked by blood eosinophil count as well as inadequately controlled CRSwNP based on P-III (SWIFT & ANCHOR) trials, respectively   SWIFT-1 (n=382) & SWIFT-2 (n=380) trials assessed depemokimab vs PBO + SoC, ICS & controller…

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