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

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  • 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 Lancet
  • Interim analysis of the ongoing OLE study, with a median Andembry exposure of 13.8mos., demonstrated favorable long-term safety & sustained reductions in HAE attacks; data was published in Allergy

Ref: Newswire.CA | Image: CSL | Press Release

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

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