European Commission approves CSL’s Andembry (garadacimab) for the prevention of recurrent attacks of hereditary angioedema (HAE)

CSL announced that the European Commission (EC) has approved Andembry (garadacimab), the first and only once-monthly treatment targeting factor XIIa to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older. Andembry inhibits plasma protein factor XIIa, which initiates the cascade of events leading to angioedema at various sites of the body.

Andembry reinforces CSL’s decades-long commitment to delivering innovative treatment modalities to the HAE community and comes with a convenient patient-centric pre-filled pen (auto-injector) enabling subcutaneous self-injection.

Bill Mezzanotte MD, Executive Vice President and Head of R&D at CSL, said: “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 optimization and our decades-long journey to bring this innovation to patients. Thank you to all the colleagues, physicians and patients who contributed to this exciting milestone for HAE patients and CSL.”

Henrik Balle Boysen, President of HAE International (HAEi), said: “Garadacimab, a novel once monthly subcutaneous treatment that inhibits activated Factor XII, is a welcome addition to the HAE treatment landscape. People with HAE now have another choice for lessening the burden associated with this lifelong condition and realizing the community’s shared goal of experiencing life to the fullest.”

(Source: CSL)