The Food and Drug Administration (FDA) has approved Actemra SC (tocilizumab solution for subcutaneous injection; Genentech) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) alone or in combination with methotrexate in patients ≥2 years old.
Previously, just the intravenous formulation of Actemra was FDA-approved for this indication. “We are pleased to now offer physicians the flexibility to prescribe for children 2 years of age and older either Actemra IV, administered in a medical office, or Actemra subcutaneous, a prefilled syringe that can be injected at home,” said Sandra Horning, MD, chief medical officer and head of Global Product Development.
The approval of the SC formulation for this patient population was based on data from the JIGSAW-118 study, a 52-week, open-label, multicenter, pharmacokinetic (PK)/pharmacodynamic (PD) study which enrolled 51 patients aged 1-17 years with SJIA. Patients were either naïve to Actemra SC (N=26) or were receiving Actemra IV and switched to the SC formulation at baseline (N=25). The efficacy of Actemra SC was based on PK exposure and extrapolation of the established efficacy of Actemra IV in SJIA.
According to the prescribing information, when transitioning from Actemra IV therapy to SC administration, the first SC dose should be administered when the next scheduled IV dose is due. For SJIA patients, Actemra SC may be self-injected by the patient or patient’s caregiver if both the clinician and the parent/legal guardian determines it is appropriate.
For more information visit Gene.com.