Submission of twos BLAs at FDA for Tremfya (guselkumab) for juvenile patients in plaque psoriasis and juvenile psoriatic arthritis – Johnson & Johnson

Johnson & Johnson  announced the submission of two supplemental Biologics License Applications (sBLAs) to the FDA seeking approval of Tremfya (guselkumab) 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 (jPsA).

The PsO submission is based on data from the Phase III  PROTOSTAR study in pediatric patients with moderate to severe plaque PsO and bridging pharmacokinetic (PK) data from the Phase III 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 (DISCOVER 1 and 2) and Tremfya efficacy and safety data from the PROTOSTAR study,.

“This milestone underscores our commitment to transform the standard of care for patients of all ages and builds on our expertise and legacy in IL-23 and immune-mediated diseases,” said Liza O’Dowd, M.D., Vice President, Immunodermatology Disease Area Leader, Johnson & Johnson Innovative Medicine. “There is a critical gap in the treatment of children and adolescents with these skin and joint conditions, where debilitating symptoms can present challenges related to physical appearance and ability to function. At Johnson & Johnson, we are working to address this gap by investigating the efficacy and well-characterized safety profile of Tremfya or pediatric patients.”

Tremfya is the first approved monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor. IL-23 is an important driver of immune-mediated diseases such as plaque PsO and PsA.

ABOUT THE PHASE III PROTOSTAR STUDY (NCT03451851); PROTOSTAR is a Phase III, multicenter, randomized, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered Tremfya for the treatment of chronic plaque psoriasis in pediatric patients six years of age and older. Co-primary endpoints of the study were Investigator’s Global Assessment (IGA) 0/1 and PASI 75 at Week 16.

ABOUT THE PHASE III VOYAGE STUDIES (NCT02207231 and NCT02207244); VOYAGE 1 and 2 were Phase III randomized, double-blind, placebo- and active comparator-controlled studies designed to evaluate the efficacy and safety of Tremfya compared with placebo and adalimumab in adults with moderate to severe plaque PsO. The co-primary endpoints of the studies were the proportions of patients receiving Tremfya versus patients receiving placebo achieving Investigator’s Global Assessment (IGA) 0/1 (clear/almost clear skin) and PASI 90 at week 16.