New psoriasis drug! Johnson and Johnson IL-12/23 inhibitor Stelara (Sidano) was approved by the U.S. FDA for the treatment of pediatric patients aged 6-11.

July 31, 2020 // Johnson and Johnson (JNJ) Janssen Pharmaceuticals (JNJ) recently announced that the U.S. Food and Drug Administration (FDA) has approved the anti-inflammatory drug Stelara (Chinese product name: Starno, generic name: ustekinumab, Ustenu mono-anti-injection) expanded indications for the treatment of moderate to severe plaque type psoriasis (PsO) pediatric patients (ages 6-11).
in the Eu, Stelara was approved in January 2020 for patients with moderate to severe PsO pediatrics (6-11 years).
previously, Stelara was approved for use in moderate and severe PsO adolescents (s12 years) and adult patients.
now, Stelara is the first and only targeted IL-12/IL-23 biologic spent in PsO pediatric patients (6-11 years), which will provide these patients with a new treatment option.
medication, Stelara was administered by subcutaneous injection, four times a year after the initial dose.
plaque type psoriasis (PsO) is the most common type of psoriasis in adults and children.
the disease is an immune-mediated inflammatory disease that affects the skin, causing redness or inflammation of the skin, which is covered with red squamous patches.
estimates are that as many as 125 million people worldwide, more than 8 million in the United States suffer from the disease, and nearly a quarter of PsO patients have moderate to severe illnesses.
about one-third of psoriasis patients develop their first symptoms before the age of 20, and about 20,000 children under the age of 10 are diagnosed with psoriasis.
the disease has far-reaching, long-term effects on children's mental health and overall quality of life.
children's psoriasis is also associated with a high incidence of low self-esteem and has long-term effects in adulthood and later life.
FDA approved Stelara for use in pediatric patients, based on the results of the Phase III CADMUS Junior study, which builds on previous Stage III CADMUS studies.
study found that Stelara treatment significantly improved the symptoms and signs of plaque psoriasis in pediatric patients ages 6-11, as well as health-related quality of life (HrQOL).
CADMUS Junior is an open-label, single-arm, multicenter 3 clinical trial of 44 patients with moderate to severe plaque psoriasis.
results showed that after receiving 2 doses of treatment, at the 12th week, 77% of patients had skin damage completely or almost completely removed.
secondary endpoints include: the 12th week of treatment, the proportion of patients with a 75% or 90% improvement in the psoriasis area and severity index (PASI) score compared to the baseline.
results showed that 84% and 64% of patients achieved PASI75 and PASI90 remission, respectively.
overall, the safety observed in the CADMUS Junior trial was similar to that observed in adult plaque psoriasis studies.
Selara is the world's first biological agent that can selectively target both IL-12 and IL-23.
IL-12 and IL-23 are two naturally occurring cytokines that are thought to play a key role in immune-mediated inflammatory diseases, including UC, plaque-type psoriasis, psoriasis arthritis, Crohn's disease, and others.
Stelara inhibits these two pre-inflammatory cytokines by binding to the p40 subkeys shared with IL-12 and IL-23, preventing it from binding to the cell surface receptor IL-12 beta1.
Stelara, which was listed in September 2009, has been approved for treatment: (1) adolescents with moderate to severe plaque type psoriasis (s6 years of age) and adult patients;
in China, Stelera (Sidano ®) is on the market in June 2019 as an innovative drug-giving model - a biologic that is injected every three months for the treatment of patients with severe difoper in adults who do not respond, have a taboo or tolerate other systems such as cyclosporine, methotrexate (MTX) or VAPU (osteolipidin and UVA).
Stelara is a core product of Johnson and Johnson's forogenic diseases, which generated sales of $6.361 billion in 2019.
in January, a top international journal, Nature, noted that With the increasing number of adaptations, expanding markets and penetration, Stelara is expected to generate sales of $7.241 billion in 2020, ranking 7th in the World's Best-Selling TOP 10 Drug by 2020.
() Original source: U.S. Food and Drug Drug Approves STELARA (ustekinumab) for Treatment of Pediatric Patients with Moderate to Plaque Severe Psoriasis.