Application filed to the European Medicines Agency for TREMFYA® to treat children with moderate to severe plaque psoriasis
Beerse, Belgium (3 February, 2025) – Johnson & Johnson today announced the submission of TREMFYA® (guselkumab) for the treatment of children 6 years and older with moderate to severe plaque psoriasis (Pso) to the European Medicines Agency (EMA).a Whilst Pso has a long-term effect on all patients, it is particularly challenging for the paediatric patient population, having a profound lasting impact on the psychological health of affected children.1
The submission is based on data from the Phase 3 PROTOSTAR study in paediatric patients with moderate to severe plaque Pso and bridging pharmacokinetic (PK) data from the Phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque Pso.b,2,3,4
IL-23 is an important driver of immune-mediated diseases such as plaque Pso.5 Guselkumab 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.6
Editor’s Notes
a. Guselkumab is not currently approved to treat moderate to severe paediatric plaque Pso.
b. Data extrapolation is the process of estimating future trends or effects based on previous observations. With limited paediatric patients available for clinical trial inclusion, researchers can extrapolate data from adult patient trials to determine the potential efficacy and tolerability of a treatment for the paediatric population.
ABOUT THE PHASE 3 PROTOSTAR PROGRAMME (EudraCT 2017-003053-42)2
PROTOSTAR is a Phase 3, multi-centre, randomised, placebo- and active comparator-controlled study evaluating the efficacy, safety, and pharmacokinetics of subcutaneously administered guselkumab for the treatment of chronic plaque Pso in paediatric 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 16.2
ABOUT THE PHASE 3 VOYAGE STUDIES (EudraCT 2014-00719-15 and EudraCT 2014-000720-18)3,4
VOYAGE 1 and 2 were Phase 3 randomised, double-blind, placebo- and active comparator-controlled studies designed to evaluate the efficacy and safety of guselkumab 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 guselkumab versus patients receiving placebo achieving IGA 0/1 (clear/almost clear skin) and PASI 90 at week 16.3,4
ABOUT PAEDIATRIC PLAQUE PSORIASIS
Pso is an immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful.7 Almost one-third of Pso cases begin in childhood.1 Paediatric Pso can have a profound long-term impact on the psychological health of affected children. Additionally, paediatric Pso has been associated with certain comorbidities, such as obesity, hypertension, hyperlipidemia, diabetes mellitus and rheumatoid arthritis.1
ABOUT GUSELKUMAB
Developed by Johnson & Johnson, guselkumab is the first approved fully-human monoclonal antibody that selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor.6 IL-23 is an important driver of the pathogenesis of inflammatory diseases.5
Guselkumab is approved in the U.S., Canada, Japan, and a number of other countries for the treatment of adults with moderate to severe plaque Pso who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis.8,9,10 It is also approved in the EU for the treatment of moderate to severe plaque Pso in adults who are candidates for systemic therapy and for the treatment of active psoriatic arthritis (PsA) in adult patients who have had an inadequate response or who have been intolerant to a prior disease-modifying antirheumatic drug therapy.6
Johnson & Johnson maintains exclusive worldwide marketing rights to guselkumab.
GUSELKUMAB IMPORTANT SAFETY INFORMATION
In controlled periods of clinical studies with guselkumab, adverse drug reactions (ADRs) that consisted of respiratory tract infections were very common (≥10 percent); increased transaminases, headache, diarrhoea, arthralgia, and injection site reactions were common (≥1 to <10 percent); and herpes simplex infections, tinea infections, gastroenteritis, decreased neutrophil count, hypersensitivity, anaphylaxis, urticaria and rash were uncommon ADRs (≥0.1 percent to <1 percent).6
Please refer to the Summary of Product Characteristics for full prescribing information for guselkumab in Pso and PsA: https://www.ema.europa.eu/en/documents/product-information/tremfya-eparproduct-information_en.pdf.
ABOUT JOHNSON & JOHNSON
At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/emea. Follow us on LinkedIn. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies.
Cautions Concerning Forward-Looking Statements
This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding TREMFYA®. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
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