New anti-inflammatory drugs! Stellara, an IL-12 / 23 inhibitor of Johnson & Johnson, has been approved by the European Union to treat pediatric patients with plaque psoriasis aged 6-11 years!

January 24, 2020 / bioun / -- Janssen Pharmaceutical, a subsidiary of JNJ, recently announced that the European Commission (EC) has approved to expand the use of stellara (Chinese trade name: sidano, generic name: ustekinumab, ulinumab injection) for the treatment of pediatric patients with moderate to severe plaque psoriasis (6-11 years old) Previously, stelara was approved for use in adolescents and adults 12 years and older with plaque psoriasis Now, stelara is the first selective IL-23 / IL-12 biological preparation for pediatric patients aged 6-11 years IL-23 / IL-12 pathway is an important target of the disease One third of Europe's 14 million cases of psoriasis begin in childhood Psoriasis is an immune-mediated inflammatory disease It will affect the skin, causing skin redness or inflammation The skin is covered with silver scales, called plaques This disease will have a profound and long-term impact on children's mental health and overall quality of life Psoriasis in children is also associated with a high incidence of low self-esteem and has a long-term impact on adulthood and beyond This approval is based on the results of the phase III Cadmus Jr study, which was based on the previous phase III Cadmus study The study found that stelara treatment significantly improved the symptoms and signs of plaque psoriasis in pediatric patients aged 6-11 years, as well as the health-related quality of life (HRQOL) Selara is the world's first biologics that can selectively target IL-12 and IL-23 at the same time IL-12 and IL-23 are two natural cytokines, which are believed to play a key role in immune-mediated inflammatory diseases, including UC, plaque psoriasis, psoriatic arthritis, Crohn's disease, etc Stelara inhibits these two proinflammatory cytokines by binding to P40 subunits shared by IL-12 and IL-23 and preventing their binding to cell surface receptor IL-12 β 1 Stelara was launched on the market in September 2009 At present, the approved indications include: (1) young people (≥ 6 years old) with moderate and severe plaque psoriasis and adult patients; (2) adult patients with active psoriatic arthritis; (3) adult patients with moderate and severe Crohn's disease (CD); and (4) adult patients with moderate and severe active ulcerative colitis (UC) In China, stelara (sidano ®) was launched in June 2019 It is a biological preparation with an innovative drug delivery mode - subcutaneous injection once every three months for the maintenance period, which is used to treat adult patients with moderate and severe plaque psoriasis who are not responsive, contraindicated or intolerable to other systems such as cyclosporine, methotrexate (MTX) or PUVA (psoralen and ultraviolet A) Stellara is a core product of Johnson & Johnson's entry into the field of autoimmune diseases In 2019, the drug generated $6.361 billion in sales, an increase of 23.4% over 2018 Recently, an article published in the top international journal Nature (top product forecasts for 2020) pointed out that with the continuous increase of indications, the continuous expansion and penetration of the market, stelara's sales volume in 2020 is expected to reach 7.241 billion US dollars, ranking 7th in the world's best selling top 10 drugs in 2020 The European Commission approved expanded use of Janssen's stellara ® (ustekinumab) for the treatment of paediatric patients with modern to severe plaque psoriasis