What is garadacimab-ANDEMBRY a drug for?

Garadacimab (garadacimab)-ANDEMBRY is a monoclonal antibody directed against activated factor XII (FXIIa), primarily used to prevent attacks of hereditary angioedema (HAE) in adults and children 12 years of age and older. HAE is a rare and potentially life-threatening genetic disease primarily caused by defects or dysfunction of C1 inhibitory protein (C1INH), an important protein that regulates inflammatory responses in the blood. The main characteristic of HAE is the abnormal accumulation of fluid in the body's tissues, resulting in swelling that usually affects the face, abdomen, throat, and extremities.

Gadaximab prevents HAE attacks by targeting activated factor XII (FXIIa), the first activating protein in the cascade that triggers HAE attacks. Compared with other HAE treatments that target downstream mediators, gadaximab can inhibit this cascade at an earlier stage, thereby effectively reducing the incidence of HAE attacks.

The drug's safety and efficacy were approved by the Food and Drug Administration (FDA) based on data from the pivotal placebo-controlled Phase 3 VANGUARD trial. The trial results showed that 62% of patients treated with gadaximab were able to maintain a seizure-free state during the entire treatment period. The median number of HAE episodes was significantly reduced by more than 99% compared with the placebo group, while the least squares mean was reduced by 89.2%. In addition, the median number of HAE episodes treated with on-demand treatment was reduced by more than 99%, with an average reduction of 88%; the median number of moderate or severe episodes was also reduced by more than 99%, with an average reduction of 90%.

Gadaximab is administered as a monthly subcutaneous injection that can be self-administered by patients via a single-dose prefilled autoinjector or a single-dose prefilled syringe. This convenient delivery method gives patients more flexibility during treatment.

Reference materials:https://www.andembryhcp.com/