Johnson & Johnson Stelara receives FDA approval for use in children with moderate to severe plaque psoriasis

On July 30, Johnson and Johnson's Xi'an Jansen announced that the U.S. FDA had approved its anti-inflammatory drug Stelara (ustekinumab, ustenuma) for moderate to severe plaque psoriasis (PsO) in children (ages 6-11).

. Stelara is a monoclonal antibody that targets leukocyte interleukin 12 (IL-12) and leukocyclus interleukin 23 (IL-23) to inhibit the binding of il-12 to IL-23-common p40 subunits to block its binding to cell surface receptors, thereby suppressing these two pre-inflammatory cytokines.
IL-12 and IL-23 are naturally occurring proteins and are thought to play a key role in inflammatory diseases, including psO, which are immune-mediated.
Stelara, which was listed in 2009, has been approved for a number of therapeutic indications, including: moderate to severe PsO adolescents (?12 years old) and adult patients (?18 years);

fda approved Stelara for psO children, primarily based on the results of a Phase 3 clinical trial CADMUS Junior, an open-label, one-arm, multicenter study involving 44 patients with moderate to severe PsO patients, 77 percent of whom significantly improved or disappeared from the skin plaques at the 12th week after receiving two doses of Stelara treatment.
the secondary endpoint of the study, the proportion of patients who scored 75 or 90 percent more patients at the 12th week when the psoriasis area and severity index (PASI) scored was compared to the baseline.
results showed that 84% and 64% of patients in the Stelara group reached PASI 75 and PASI 90, respectively.
the safety of Stelara observed in this study is similar to that observed in adult PsO.
, a core drug for Johnson and Johnson's autoimmune diseases, achieved sales of $6.62 billion in 2019 and is expected to maintain sales peaks in the coming years with renewed indications approval.
in China, Stelara was approved for sale in November 2017 for the treatment of moderate-to-severe PsO.
in March this year, the drug was approved for the second time, for adult patients with moderate to severe CD.
Source: U.S. Food and Drug Drug Approves STELARA (ustekinumab) for Treatment of Pediatric Patients with Moderate to Plaque Severe Psoriasis.