Shots:

• The company has submitted an sBLA to the US FDA for an expanded approval of Stelara (ustekinumab) to treat pediatric patients ≥aged 5yrs. with jPsA
• The submission is based on the extrapolation of data from the nine studies evaluating the efficacy and tolerability of Stelara in 3-997 patients across both adults with active PsA & adults & pediatric patients with PsO. The PDUFA date for the US FDA’s decision is expected in late 2022
• Stelara is the first biologic treatment targeting both IL-12 and IL-23 & is approved in the US for the treatment of mod to sev PsA in adults and children aged ≥6yrs.- active PsA in adults aged ≥18yrs.- CD & active UC

  Ref: PR Newswire | Image: Janssen