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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.