The monoclonal antibody is a self-administered injection for prophylactic use to prevent attacks<\/p>\n<\/h3>\n
By Lori Solomon HealthDay Reporter<\/b>
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FRIDAY, June 20, 2025 (HealthDay News) — 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). <\/p>\n
According to the Mayo Clinic<\/a>, 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.<\/p>\n 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.<\/p>\n 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.<\/p>\n The most common adverse reactions seen with Andembry were inflammation of the nasal passages and upper throat and abdominal pain (incidence \u22657 percent).<\/p>\n “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.<\/p>\n Approval of Andembry was granted to CSL.<\/p>\n