J&J seeks U.S. FDA approval for pediatric indications for TREMFYA

Johnson & Johnson announced the submission of two supplemental Biologics License Applications, sBLAs, to the U.S. Food and Drug Administration, FDA, seeking approval of TREMFYA for the treatment of children 6 years and older with moderate-to-severe plaque psoriasis, PsO, and children 5 years of age and older with active juvenile psoriatic arthritis. The PsO submission is based on data from the Phase 3 PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and bridging pharmacokinetic data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO. The jPsA submission is based on PK extrapolation analyses from adult PsA studies and TREMFYA efficacy and safety data from the PROTOSTAR study.