Janssen Report Submission of sBLA to the US FDA for the Approval of Stelara (ustekinumab) to Treat Juvenile Psoriatic Arthritis
Janssen Enters into a License and Collaboration Agreement with F-star to Develop and Commercialize Multiple Bispecific Antibody Therapeutics
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
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