Shots:
- The US FDA has approved Andembry (garadacimab-gxii) for HAE pts (≥12yrs); commercially available before Jun 2025 end
- 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, as well as attacks requiring on-demand therapy by >99% median & 88% mean; >99% median & 90% mean reduction was also seen in mod./sev. attacks; 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: Prnewswire | Image: CSL & Arcturus| Press Release
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