OTTAWA, Canada — August 8, 2025 — Leads & Copy — CSL (ASX:CSL; USOTC:CSLLY) announced that Health Canada has granted marketing authorization for ANDEMBRY® (garadacimab) for routine prevention of hereditary angioedema (HAE) attacks in patients aged 12+. ANDEMBRY is a monoclonal antibody targeting activated FXIIa, a plasma protein key in HAE swelling attacks. It’s authorized with a prefilled pen for subcutaneous self-injection.
ANDEMBRY is CSL’s first monoclonal antibody discovered and developed entirely by CSL, said Bill Mezzanotte, MD, Executive Vice President, Head of R&D, CSL, marking a step forward in HAE care. Dr. Stephen Betschel, Chair of the Canadian Hereditary Angioedema Network, added that it represents a significant advancement, offering a promising approach to preventing HAE attacks by addressing the underlying mechanisms.
The authorization is based on Phase 3 VANGUARD trial data, showing ANDEMBRY reduced HAE attacks by over 99% compared to placebo, with 62% of patients attack-free during treatment. Michelle Cooper, President, HAE Canada, said the authorization and future availability of ANDEMBRY for HAE is great news, calling it a significant advancement in preventing HAE attacks.
This approval builds toward global availability after recent approvals in Australia, the UK, the EU, Japan, Switzerland, and the US. HAE is a rare genetic condition affecting 1 in 10,000 to 1 in 50,000 people, causing recurrent angioedema attacks.
Valerie Bomberger, CSL, Office: +1 610-291-5388, Mobile: +1 267-280-3829, Email: valerie.bomberger@cslbehring.com
Etanjalie Ayala, CSL Behring, Mobile: +1 610 297 1069, Email: etanjalie.ayala@cslbehring.com
Greg Healy, CSL, Mobile: +1 610-906-4564, Email: greg.healy@cslbehring.com
Kim O’Donohue, CSL, Mobile: +61 449 884 603, Email: kim.odonohue@csl.com.au
Brett Foley, CSL, Mobile: +61 461 464 708, Email: brett.foley@csl.com.au
Source: CSL
