Johnson & Johnson has announced that the US Food and Drug Administration (FDA) has approved Tremfya (guselkumab) for use in children from six years of age, following positive data from multiple phase 3 studies.
The treatment is now indicated for children aged six years and older, weighing at least 40 kg, with moderate-to-severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy, as well as for children with active psoriatic arthritis (PsA).
Each year, approximately 20,000 children under the age of ten are diagnosed with plaque PsO in the US, while active PsA affects an estimated 14,000 children.
Tremfya is the first – and currently only – IL-23 inhibitor approved by the FDA for children. The decision extends the drug’s approved use, having received FDA clearance for adults with plaque PsO in 2017 and for PsA in 2020.
The plaque PsO approval was based on results from the phase 3 PROTOSTAR study in paediatric patients with moderate to severe plaque PsO and supportive data from the phase 3 VOYAGE 1 and 2 studies in adult patients with moderate to severe plaque PsO.
Approval of the active PsA indication was supported by evidence from pharmacokinetic extrapolation analyses from TREMFYA PsO and PsA studies, including VOYAGE 1 and 2, DISCOVER 1 and 2 and PROTOSTAR.
Findings from these analyses corroborate the efficacy and safety data from adults with PsO and PsA and children with moderate to severe plaque PsO to children with active PsA.
“The approval of the first and only paediatric indications for an IL-23 inhibitor marks an important step forward not only for children, but also for the parents and care partners who support them every day,” said Brandee Pappalardo, vice president, medical affairs, dermatology & rheumatology, Johnson & Johnson Innovative Medicine.