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CSL Receives Health Canada’s Approval for Andembry as a Prophylactic Treatment of Hereditary Angioedema (HAE)

Shots: Health Canada has approved Andembry (garadacimab) for HAE pts (≥12yrs)Approval 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; data was published in The LancetInterim analysis of the ongoing OLE…
August 11, 2025

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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…
June 17, 2025

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CSL Behring Receives the EC Approval for Andembry as a Prophylactic Treatment of HAE

Shots:EC has approved Andembry for HAE pts (≥12yrs) in 30 EEA states (incl. Iceland, Liechtenstein & Norway) following UK’s MHRA & Australia’s TGA approval in Jan 2025. Although, regulatory review is ongoing for the US, Switzerland, Japan & Canada Approval was based on the P-III (VANGUARD) trial (Data published in The Lancet) assessing Andembry vs PBO & OLE…
February 14, 2025

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CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE) 

     Shots:    The CHMP has recommended Andembry as a prophylactic treatment of HAE in patients (≥12 yrs.), with the EC’s decision anticipated in Q1’25, based on P-III (VANGUARD) trial & ongoing OLE study The P-III study (full results published in The Lancet) of Andembry vs PBO met its 1EP, showing attack-free status in 62% while…
December 13, 2024

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