Takeda announced the Phase 3 SHP643 to evaluate the safety and pharmacokinetics of Takhzyro (lanadelumab)
Takeda announced the Phase 3 SHP643 to evaluate the safety and pharmacokinetics of Takhzyro (lanadelumab) in pediatric patients with hereditary angioedema (HAE) aged 2 to less than 12 years - Study 301 (SPRING, NCT04070326) has been completed and its objectives have been met.
Takhzyro is the first monoclonal antibody approved for the treatment of HAE. It was approved for marketing in August 2018. The indications are: for HAE patients 12 years of age and older, routinely preventing HAE attacks. Takhzyro is not indicated for the acute treatment of HAE episodes. Takhzyro is a fully human mAb that specifically binds and inhibits the activity of plasma kallikrein. The drug is produced in Chinese hamster ovary cells (CHO) using recombinant DNA technology.