Genentech announced that the Food and Drug Administration (FDA) has approved the subcutaneous (SC) formulation of Actemra (tocilizumab) for the treatment of active polyarticular juvenile idiopathic arthritis (PJIA) in patients aged ≥2 years, as monotherapy or in combination with methotrexate.
Actemra, a humanized interleukin-6 (IL-6) receptor antagonist, is already indicated to treat rheumatoid arthritis, active systemic juvenile idiopathic arthritis, giant cell arteritis, and chimeric antigen receptor T-cell induced severe or life-threatening cytokine release syndrome (CRS).The intravenous (IV) formulation of Actemra was approved in 2013 for use in patients aged ≥2 years.
Approval of the SC formulation for this patient population was supported by data from the Phase 1b JIGSAW-117 trial, a 52-week, open-label multicenter, pharmacokinetic/pharmacodynamic bridging study (N=52) that aimed to determine the appropriate dosing regimen of Actemra SC based on body weight in children with PJIA.
The study enrolled patients aged 1–17 years with PJIA and previous inadequate response or intolerance to methotrexate who were Actemra-naive or were receiving Actemra IV with adequate disease control. Study patients were administered Actemra SC based on a body weight-based dosing regimen for 52 weeks. The data showed a consistent safety profile with Actemra SC and Actemra IV apart from injection site reactions and neutropenia.
The efficacy of Actemra SC among pediatric patients (ages 2–17) was extrapolated from established data of Actemra IV in PJIA patients and of Actemra SC in patients with rheumatoid arthritis.
For SC injection, Actemra is supplied in 162mg/0.9mL strength prefilled syringes.
For more information call (800) 228-3672 or visit Actemra.com.