[9][10] Lanadelumab, was approved in the United States as the first monoclonal antibody indicated for prophylactic treatment to prevent hereditary angioedema attacks.
[5][11] Lanadelumab is the first treatment for hereditary angioedema prevention made by using cells within a lab, not human plasma.
[5][13][15] In a phase III randomized controlled trial, which examined the efficacy and safety of lanadelumab in preventing hereditary angioedema attacks, the most common adverse events noted in patients being treated were:[16][17] Lanadelumab works by binding to an enzyme within the plasma, kallikrein, to inhibit its activity.
[18] People have hereditary angioedema because of a deficiency or dysfunctional C1 inhibitor, which is an enzyme that regulates the activity of the kallikrein-kinin cascade.
[8][19][20][21] Lanadelumab's approval in the United States was spearheaded by the data presented in the phase 1b, multicenter, double blind, placebo controlled, multi-ascending-dose trial.