Andembry FDA Approval History
Last updated by Judith Stewart, BPharm on June 17, 2025.
FDA Approved: Yes (First approved June 16, 2025)
Brand name: Andembry
Generic name: garadacimab-gxii
Dosage form: Injection
Company: CSL Behring
Treatment for: Hereditary Angioedema
Andembry (garadacimab-gxii) is an activated Factor XII (FXIIa) inhibitor (monoclonal antibody) indicated for prophylaxis to prevent attacks of hereditary angioedema in adult and pediatric patients aged 12 years and older.
- Hereditary angioedema (HAE) is a rare, genetic and potentially life-threatening condition caused by deficient or dysfunctional C1INH, a protein in the blood that helps to control inflammation. HAE is characterized by the accumulation of fluid in body tissues, causing considerable swelling (angioedema). HAE attacks can affect many parts of the body, including the face, abdomen, larynx, and extremities.
- Andembry works in the prophylaxis of HAE by inhibiting factor XIIa, the first protein activated in the HAE pathway, which initiates the cascade of events leading to an HAE attack. By targeting activated FXII (FXIIa), Andembry inhibits this cascade at the top as compared to other HAE therapies that target downstream mediators.
- FDA approval was supported by data from the pivotal placebo-controlled Phase 3 VANGUARD trial which demonstrated that treatment with Andembry:
- led to 62 percent of Andembry-treated patients remaining attack-free throughout the treatment period.
- reduced HAE attacks by a median of more than 99 percent and a least squares mean of 89.2 percent, compared to placebo.
- achieved more than 99 percent median reduction and an 88 percent mean reduction in HAE attacks requiring on-demand therapy, compared to placebo.
- attained more than 99 percent median reduction and a 90 percent mean reduction in moderate or severe attacks, compared to placebo. - Andembry is administered subcutaneously once monthly. Andembry is supplied in single-dose prefilled autoinjector and single-dose prefilled syringe presentations, allowing patients to self-administer.
- Common adverse reactions (incidence > 7%) include nasopharyngitis and abdominal pain.
Development timeline for Andembry
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.