In a major development for patients living with hereditary angioedema (HAE), the U.S. Food and Drug Administration (FDA) has approved Garadacimab‑gxii, marketed as Andembry, for the prevention of swelling attacks in people aged 12 years and older. The approval announced on June 16, 2025 introduces a first‑in‑class therapy that works differently from existing treatments.
Andembry is a monoclonal antibody designed to block activated Factor XII (FXIIa), an early trigger in the biological chain that leads to excess production of bradykinin, the substance responsible for painful and sometimes life‑threatening swelling episodes in HAE.
Pivotal phase III studies demonstrated that Andembry:
● Significantly reduced the average number of monthly HAE attacks
● Helped many patients remain attack‑free for extended periods
● Was generally well tolerated, with mild side effects like injection site reactions or headaches
The therapy is given by subcutaneous injection, offering patients a practical long‑term option to control disease activity. Hereditary angioedema is a rare genetic disorder that can cause sudden swelling of the face, limbs, abdomen, and airways, with attacks that can be life‑threatening if the throat is involved.
By targeting FXIIa, Andembry provides a novel preventive approach that could help patients who still experience attacks despite existing treatments and highlights ongoing advances in precision biologic therapies for rare diseases.
Disclaimer: This article is intended for informational purposes only and should not be taken as medical advice. Always consult a qualified healthcare professional for diagnosis, treatment options or questions regarding any medical condition or medication.
