Amgen announced that the Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded indication of Enbrel (etanercept) injection to include pediatric patients aged 4–17 years with chronic moderate-to-severe plaque psoriasis. This marks Enbrel as the first systemic therapy to treat pediatric patients with this condition.
The expanded indication approval is based on data from a Phase 3 1-year study and a 5-year open-label extension study to assess the safety and efficacy of Enbrel in pediatric patients aged 4–17 years with chronic moderate-to-severe plaque psoriasis. Treatment with Enbrel resulted in significant efficacy and the adverse event profile proved comparable to that seen in earlier studies of adult with moderate-to-severe plaque psoriasis.
Enbrel, a tumor necrosis factor (TNF) blocker, was initially approved in 1998 for moderate-to-severe rheumatoid arthritis. It received approval in 1999 to treat moderate-to-severe polyarticular juvenile idiopathic arthritis, in 2002 to treat psoriatic arthritis, in 2003 to treat ankylosing spondylitis, and in 2004 to treat moderate-to-severe plaque psoriasis in adults.
Enbrel injection is available as a 50mg/mL single-dose prefilled syringe, a single-dose prefilled SureClick autoinjector, and as a 25mg/0.5mL single-dose prefilled syringe in 4-count cartons.
For more information call (888) 4ENBREL or visit Enbrel.com.