Johnson & Johnson’s (J&J) Tremfya (guselkumab) has received approval from the US Food and Drug Administration (FDA) for paediatric patients with plaque psoriasis and active psoriatic arthritis.
This makes the drug the first ever interleukin-23 (IL-23) inhibitor to obtain approval in a paediatric population. It will be available to children six years or older who weigh at least 40kg.
The blockbuster monoclonal antibody (mAb) obtained approval based on the results of the Phase III PROTOSTAR (NCT03451851) study, which revealed the drug’s strong capacity to clear psoriatic plaques.
During the pivotal trial, it was found that 56% of patients achieved a psoriasis area severity index (PASI) score of 90% or better. PASI is a common measure used in psoriasis-focused clinical trials to measure a patient’s response to treatment.
After 16 weeks of treatment, it was also found that 40% of patients receiving Tremfya achieved complete psoriatic clearance – a significant difference from the 4% seen in the placebo group.
The drug operates through a dual mechanism, blocking IL-23 while binding to Cluster of Differentiation 64 (CD64) – a key receptor found on cells that produce IL-23.
Tremfya was first approved in adults with moderate-to-severe plaque psoriasis in 2017 – going on to obtain approval in adults with active psoriatic arthritis in 2020.
However, the subcutaneously administered drug also secured FDA clearance for ulcerative colitis (UC) and Crohn’s disease (CD) this year, with analysts at GlobalData – parent company of Pharmaceutical Technology – forecasting that the drug could “set the standard for CD treatment moving forward”.
The FDA approval of Tremfya will be welcome news for J&J, as the company named the drug as a significant contributor to the 7.5% increase in global innovative medicine sales seen in 2024.
Tremfya was also J&J’s fourth best-selling asset last year, bringing in $3.6bn for the US pharma.
While Tremfya is the only IL-12 mAb approved in paediatric patients, there are other therapies approved in the patient population including Amgen subsidiary Immunex’s Enbrel (etanercept), as well as Eli Lilly’s Taltz (ixekizumab) and Novartis’ Cosentyx (secukinumab).
Analysts at GlobalData forecast that Tremfya will earn $9.1bn for J&J by 2031.
