CHMP recommends approval of Jansen Stelara (ustekinumab) extended indications
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Last Update: 2020-06-09
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Source: Internet
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Author: User
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UC is a chronic disease of the colon caused by an abnormal response to the body's immune system, where inflammation of the inner wall of the colon occurs and ulcers are producedSymptoms of the disease include frequent defecation, persistent diarrhea, abdominal pain, blood, loss of appetite, weight loss and fatigue, which negatively affect all aspects of the patient's lifeJanssen, acompany owned http:// by Johnson and Johnson
, announcedrecently that the Europeandrug(http://Authority (EMA) recommended that the European Union (EU) approve the expansion of Steela (ustekinabum) to treat moderate lysing atives of severe active ative itisen, which are under-reacted to conventional therapies or biologicsAbout Stelara
Stelara is a human IL-12 and IL-23-specific antagonistsIL-12 and IL-23 are important cytokines in the body to regulate immune system and immunomediated inflammation, and are also important therapeutic targets for UCCHMP's recommendation is based on the Critical Phase 3 ClinicalTrial(http://project called UNIFI The results showed that in the second week of induction therapy, the proportion of patients who received a single Stelara intravenous injection without intestinal bleeding or normal stool frequency was higher than that of the placebo group For patients with the recommended dose of Stelara, 62% received clinical remission in the eighth week after treatment, compared with 31 % in the placebo group (p0.001) The results showed that the proportion of patients receiving subcutaneous stelara maintenance therapy achieved clinical remission was significantly higher than in the control group
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