Johnson & Johnson Submit Two License Applications to FDA for Pediatric Indications
Johnson & Johnson has submitted two supplemental Biologics License Applications (sBLAs) to the FDA for TREMFYA® (guselkumab). The applications seek approval to treat moderate-to-severe plaque psoriasis in children aged 6 and older and active juvenile psoriatic arthritis in children aged 5 and older. The plaque psoriasis submission is supported by data from the Phase 3 PROTOSTAR study in children and bridging data from adult Phase 3 VOYAGE 1 and 2 studies. The juvenile psoriatic arthritis submission relies on pharmacokinetic analyses from adult PsA studies (DISCOVER 1 and 2) and safety and efficacy data from the PROTOSTAR study.
Johnson & Johnson Submit Two License Applications to FDA for Pediatric Indications