CSL has received approval from the European Commission (EC) for Andembry (garadacimab) to prevent recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and above.
The therapy targets factor XIIa and is designed to prevent the attacks with a once-monthly, self-administered dose via a pre-filled auto-injector.
The approval is supported by the outcomes from the international Phase III VANGUARD trial and its subsequent open-label extension trial.
These studies demonstrated the treatment’s safety and efficacy.
Andembry’s centralised marketing authorisation means it will be accessible across all European Union member states and in the European Economic Area (EEA) countries Norway, Iceland and Liechtenstein.
Beyond Europe, the therapy is under regulatory review in Japan, Canada, Switzerland and the US.
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By GlobalDataCSL research and development head and executive vice-president Bill Mezzanotte stated: “Andembry is a significant advancement in the management of hereditary angioedema, offering people living with this life-threatening condition long-term control over their disease with a patient-centric, convenient administration method.
“Andembry, CSL’s first approved recombinant monoclonal antibody discovered and developed entirely by CSL, underscores our more than 40-year legacy in HAE research and treatment optimisation and our decades-long journey to bring this innovation to patients.”
As a factor XIIa-inhibitory monoclonal antibody, Andembry offers a unique approach to HAE treatment by blocking the plasma protein FXIIa, which is responsible for initiating the cascade of events resulting in angioedema.
It was developed by the company scientists at the Bio21-based research site and manufactured at the CSL Broadmeadows Biotech facility.
The therapy received approvals from the UK’s Medicines and Healthcare products Regulatory Agency and the Australian Therapeutic Goods Administration.
CSL has a portfolio that includes treatments for haemophilia and immune deficiencies, influenza vaccines and therapies for iron deficiency and nephrology.
