Johnson & Johnson (NYSE: JNJ), a US-based healthcare company, announced on Monday that the US Food and Drug Administration has approved TREMYFA (guselkumab) for paediatric patients aged six years and older, weighing at least 40 kg, with moderate to severe plaque psoriasis or active psoriatic arthritis.

The company says that TREMYFA is now the first and only IL-23 inhibitor cleared for these paediatric indications. It is administered via subcutaneous injection at Week 0, Week 4, and every 8 weeks thereafter, with a recommended dosage of 100 mg.

The approval for plaque psoriasis was supported by the Phase 3 PROTOSTAR study, which showed significant improvements in skin clearance compared to placebo at Week 16, with data from the VOYAGE 1 and 2 adult studies further supporting efficacy and safety outcomes. For psoriatic arthritis, approval was based on extrapolated pharmacokinetic analyses across multiple trials, including PROTOSTAR and DISCOVER.

Johnson & Johnson highlighted that approximately 20,000 children under age 10 are diagnosed annually with plaque psoriasis, while around 14,000 are affected by psoriatic arthritis. The company emphasised the unmet need for therapies addressing both the physical and emotional impact of these conditions.

This FDA decision follows recent approvals of TREMYFA in adults with ulcerative colitis and Crohn's disease, reflecting Johnson & Johnson's strategy to expand the drug's therapeutic reach.