FDA to Review Stelara for Adolescent Psoriasis
Janssen Biotech announced the submission of a supplemental Biologics License Application (sBLA) to the Food and Drug Administration (FDA) for Stelara (ustekinumab) to treat adolescents (12–17 years old) with moderate to severe plaque psoriasis.
Stelara, a human monoclonal antibody, works by targeting interleukin (IL)-12 and IL-23 cytokines. It is currently approved to treat adults with moderate to severe plaque psoriasis, as well as psoriatic arthritis, and moderately to severely active Crohn's disease.
The sBLA included data from the Phase 3, randomized, double-blind, placebo-controlled, parallel, multicenter CADMUS registration study that evaluated the safety and efficacy of Stelara in the treatment of 110 adolescents with moderate to severe plaque psoriasis. Patients were randomized to receive subcutaneous (SC) injections of placebo, Stelara standard dosing, or Stelara half dosing.
The primary endpoint was a Physician's Global Assessment (PGA) score of cleared (0) or minimal (1) at Week 12. The safety and efficacy profile of Stelara in the study proved consistent with the profile seen in adults treated with Stelara
The currently ongoing Phase 3 study, CADMUS Jr, is evaluating the safety and efficacy of Stelara in the treatment of pediatric patients aged 6–11 years with moderate to severe plaque psoriasis.
Stelara is available as 45mg/0.5mL and 90mg/mL strength solutions for SC injection or as 130mg/26mL solution for IV infusion.
For more information call or visit Stelara.com.