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 study (primary data published in Allergy) in HAE pts
- Andembry (QM, SC pre-filled pen) is a Factor XIIa-inhibitory mAb and targets activated factor XII, whic is responsible for swelling attacks which leads to edema formation in HAE patients. Andembry to be produced at at the CSL Broadmeadows Biotech facility.
Ref: CSL | Image: CSL
Related News:- CSL Behring’s Andembry (Garadacimab) Receives Positive CHMP Opinion to Treat Hereditary Angioedema (HAE)
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