Takeda Pharmaceutical: FDA approves sBLA for expanded use of TAKHZYRO

Takeda announced that the U.S. FDA has approved the supplemental Biologics License Application for the expanded use of TAKHZYRO for prophylaxis to prevent attacks of hereditary angioedema in pediatric patients 2 to less than12 years of age. Prior to this approval, the only approved routine prophylaxis treatment options for children 6 to less than12 years of age required dosing every three to four days, and children with HAE 2 to less than 6 years of age had no approved prophylaxis treatment, making TAKHZYRO the first prophylaxis treatment for this age group. The recommended dose is 150 mg/1 mL solution in a single-dose prefilled syringe every four weeks in patients 2 to less than 6 years of age and every two weeks in patients 6 to less than 12 years of age.