The safety and efficacy of ZYNTEGLO have been established in pediatric patients with beta-thalassemia requiring regular transfusions. Use of ZYNTEGLO is supported by two phase 3 studies that included 27 pediatric patients in the following age groups: 16 children (less than 12 years) and 11 adolescents (age 12 years to less than 18 years). The safety and efficacy of ZYNTEGLO in children less than 4 years of age have not been established. No data are available.