Janssen Report Submission of sBLA to the US FDA for the Approval of Stelara (ustekinumab) to Treat Juvenile Psoriatic Arthritis

October 11, 2021 Auto Bot FDA, Janssen, regulatory, sBLA, Stelara, ustekinumab 0

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

Click here to­ read full press release/ article | Ref: PR Newswire | Image: Clinical Trial Arena

The post Janssen Report Submission of sBLA to the US FDA for the Approval of Stelara (ustekinumab) to Treat Juvenile Psoriatic Arthritis first appeared on PharmaShots.