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 reducing the median HAE attacks to 0 & mean HAE attacks/month by 86.5%. OLE study depicted sustained attack reduction & favorable long-term safety (primary results published in Allergy)
- Garadacimab (QM) targets activated factor XII, responsible for attacks of swelling in HAE patients, to inhibit the HAE cascade thereby preventing attacks
Ref: CSL Behring | Image: CSL Behring
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