EC approves CSL’s Andembry

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.

Developed by Australia’s CSL Limited (ASX: CSL) and to be marketed by its CSL Behring unit, 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, the company noted.

CSL Behring will make Andembry available for eligible people upon completion of access and reimbursement negotiations.