Johnson and Johnson have filed a license application for stelara's complementary biologics with the FDA.
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Last Update: 2020-06-10
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Source: Internet
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Author: User
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recently, jansonPharmaceutical(http://, owned bypharmaceutical(http:// jnd), announced(http:// that it had submitted an application for a supplemental biological productlicense (sBLA) to the u.SFood andDrug(http://Administration (http://Used to treat adult patients with moderate to severe active ulcerative colitis (UC)About Stelara
Stelara is the first and only biological agent to target IL-12 and IL-23, and there is evidence that these two cytokines play an important role in autoimmune disease-related inflammation, such as UCso far, Stelara has been approved by many countries, including the United States, for treatment of moderate lycinated psoriasis, active psoriasis arthritis and moderate to severe Crohn's diseaseStelara is a mono-anti-inflammatory drug that targets leukocyte interleukin 12 (IL-12) and leukocyte interleukin 23 (IL-23) Stelara can suppress these two preinflammatory cytokines by combining with the p40 subunits common to IL-12 and IL-23 to prevent it from being combined with the receptor IL-12 beta1 on the cell surface IL-12 and IL-23 are two naturally occurring proteins that are thought to play a key role in immune-mediated inflammatory diseases, including plaque-type psoriasis, psoriasis arthritis, Crohn's disease, systemic lupus, and more Stelara is a core product in the field of autoimmune diseases (http:// , and in the United States, Stelara was launched in 2009 and has been approved for indications including: (1) for light therapy or system therapy for moderate to severe spots and above Adolescent and adult patients with block psoriasis; (2) for adult patients with active psoriasis arthritis at age 18 and older as a single drug or combined methotrexate; and (3) adult patients with Crohn's disease (CD) who have failed or intolerant treatment with other medications the submission of the sBLA is based on data from phase III UNIFI's global clinical development program, which included 2 studies (1 induction study and 1 maintenance study) to assess the efficacy and safety of Stelara's treatment of adults with moderate to severe active UC data from phase III induction studies were released at the 2018 annual meeting of the American Gastroenterology Society and the European Joint Gastroenterology Society Data from the Phase III maintenance study will be presented at the (http:// of the 2019 Conference on Medical
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