FDA Approves Once-Monthly Andembry for Hereditary Angioedema

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By Lori Solomon HealthDay Reporter

Medically reviewed by Drugs.com

via HealthDay

FRIDAY, June 20, 2025 -- The U.S. Food and Drug Administration has approved Andembry (garadacimab-gxii) as the only treatment targeting factor XIIa for prophylactic use to prevent attacks of hereditary angioedema (HAE).

According to the Mayo Clinic, angioedema is "a reaction similar to hives that affects deeper layers of the skin. It can appear with hives or alone." Symptoms include welts that form in minutes to hours; swelling, particularly around the eyes, cheeks, or lips; and some mild pain.

The approval of Andembry is for use in adult and pediatric patients aged 12 years and older and is self-administered with once-monthly dosing delivered in 15 seconds or less via an autoinjector with a citrate-free formula. Andembry targets factor XIIa, a plasma protein that plays a key role in attacks of swelling in people with HAE.

The approval is based on results from a phase 3 study. Findings showed that 62 percent of Andembry-treated patients remained attack-free throughout the six-month study period. Andembry reduced HAE attacks by a median of more than 99 percent compared with placebo. Additionally, Andembry was associated with a 99 percent median reduction and an 88 percent mean reduction in HAE attacks needing on-demand therapy compared with placebo, as well as a 99 percent median reduction and a 90 percent mean reduction in moderate or severe attacks.

The most common adverse reactions seen with Andembry were inflammation of the nasal passages and upper throat and abdominal pain (incidence ≥7 percent).

"Andembry, the first monoclonal antibody discovered and developed entirely by CSL, offers people living with this life-threatening condition long-term control over their disease along with a convenient administration method," Bill Mezzanotte, M.D., head of research and development at CSL, said in a statement.

Approval of Andembry was granted to CSL.

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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.

Source: HealthDay

Posted : 2025-06-21 12:00

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