TABLE 1.
Pooled approved doses | Pooled other doses studied | All doses (approved + other) a |
---|---|---|
LIBERTY AD PEDS (aged 6–11) | ||
200 mg q2w (≥30 kg) | 100 mg q2w (<30 kg) | 100/200 mg q2w |
300 mg q4w b , c | 300 mg q4w | |
LIBERTY AD ADOL (aged 12–17) | ||
200 mg q2w (<60 kg) | 300 mg q4w | 200/300 mg q2w |
300 mg q2w (≥60 kg) | 300 mg q4w |
Abbreviations: EMA, European Medicines Agency; FDA, Food and Drug Administration; q2w, every 2 weeks; q4w, every 4 weeks.
All doses include both approved doses and other doses studied as per the LIBERTY AD PEDS and LIBERTY AD ADOL study designs.
FDA approved for children (aged 6–11 years) <30 kg, and EMA approved for children (aged 6–11 years) 15–60 kg.
Per EMA recommendation, the dose may be increased to 200 mg every other week based on the doctor's opinion.