Janssen Announces FDA Approval of Stelara (Ustekinumab) for Pediatric Patients Aged 6–11 with Moderate to Severe Plaque Psoriasis

July 31, 2020 News /BioValleyBIOON/ -- Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (JNJ), recently announced that the U.S. Food and Drug Administration (FDA) has approved the expansion of indications for the anti-inflammatory drug Stelara (Chinese brand name: Xidano; generic name: ustekinumab, ustekinumab injection) for the treatment of pediatric patients (aged 6–11 years) with moderate-to-severe plaque psoriasis (PsO).

In the European Union, Stelara was approved in January 2020 for pediatric patients (aged 6–11 years) with moderate-to-severe PsO. Previously, Stelara had been approved for adolescent (≥12 years) and adult patients with moderate-to-severe PsO. Now,Stelara is the first and only targeted IL-12/IL-23 biologic for pediatric patients (6–11 years) with PsO, will provide a new treatment option for these patients. Regarding administration, Stelara is administered via subcutaneous injection, with four doses per year after the initial dose.

Plaque Psoriasis (PsO) is the most common form of psoriasis in both adults and children. It is an immune-mediated inflammatory disease that affects the skin, causing redness or inflammation and resulting in red, scaly patches on the skin. It is estimated that up to 125 million people worldwide and more than 8 million people in the United States are affected by this condition, with nearly one-quarter of PsO patients having moderate-to-severe disease. Approximately one-third of psoriasis patients experience their first symptoms before the age of 20, including approximately 20,000 children under the age of 10.DiagnosisPsoriasis. This disease has profound and long-term impacts on children's mental health and overall quality of life. Pediatric psoriasis is also associated with a high prevalence of low self-esteem and can have lasting effects into adulthood and later life.

FDAApproval of Stelara for pediatric patients, based on the results of the Phase III CADMUS Junior study, which builds upon the prior Phase III CADMUS study. The study found that treatment with Stelara significantly improved the signs and symptoms of plaque psoriasis in pediatric patients aged 6 to 11 years, while also improving health-related quality of life (HrQOL).

CADMUS Junior is an open-label, single-arm, multicenter Phase 3Clinical TrialsThe study included 44 pediatric patients with moderate-to-severe plaque psoriasis. Results showed that at Week 12, after two doses of treatment, 77% of patients achieved complete or almost complete clearance of skin lesions. Secondary endpoints included the proportion of patients achieving a 75% or 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) score at Week 12. The results indicated that 84% and 64% of patients achieved PASI 75 and PASI 90 responses, respectively. Overall, the safety profile observed in the CADMUS Junior trial was similar to that reported in studies of adult patients with plaque psoriasis.

Selara is the world’s first biologic agent capable of simultaneously and selectively targeting IL-12 and IL-23. IL-12 and IL-23 are two naturally occurring cytokines believed to play a key role in immune-mediated inflammatory diseases, including ulcerative colitis (UC), plaque psoriasis, psoriatic arthritis, and Crohn’s disease. Stelara inhibits these two pro-inflammatory cytokines by binding to the p40 subunit shared by IL-12 and IL-23, thereby blocking their interaction with the cell surface receptor IL-12β1.

Stelara was launched in September 2009, and its currently approved indications include the treatment of: (1) adolescents (aged ≥6 years) and adults with moderate to severe plaque psoriasis; (2) adults with active psoriatic arthritis; (3) adults with moderate to severe Crohn's disease (CD); (4) adults with moderate to severe active ulcerative colitis (UC).

In China, Stelara® (Xidano®) was launched in June 2019. This biologic agent features an innovative dosing regimen—once every three months via subcutaneous injection during the maintenance phase—and is indicated for the treatment of adult patients with moderate-to-severe plaque psoriasis who are non-responsive to, have contraindications for, or are intolerant of other systemic therapies, such as cyclosporine, methotrexate (MTX), or PUVA (psoralen plus ultraviolet A).

Stelara is Johnson & Johnson's entry intoAutoimmunitya core product in the field of sexual health, which achieved sales of $6.361 billion in 2019. In January this year, an article published in the prestigious international journal Nature (Top product forecasts for 2020) pointed out that with the continuous expansion of indications, market growth, and penetration, Stelara’s sales were projected to reach $7.241 billion in 2020, ranking seventh among the “Top 10 Best-Selling Drugs Worldwide in 2020.” (Bioon.com)

Original Source:U.S. Food and Drug Administration Approves STELARA (ustekinumab) for Treatment of Pediatric Patients with Moderate to Severe Plaque Psoriasis