FDA approves Rituxan for treatment of adult patients with moderate to severe normal herpes
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Last Update: 2020-06-11
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Source: Internet
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Author: User
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recently, SwissPharmaceuticalsannounced that the U.SFood andDrug(
FDA
(
FDA) has approved the treatment of adult patients with moderate to severe normal type of osteophlys (PV) with rituximab, common name: rituximabRituxan
Rituxan is a therapeutic monoclonal antibody that targets CD20 antigens that bind to normal and malignant B cell surfaces and then mobilizes the body's natural defenses to attack and kill labeled B cellsAccording to the FDA's decision today, Rituxan has now been approved for the treatment of four autoimmune diseases, including rheumatoid arthritis (RA), granuloma polyvascularitis (GPA), microphenysis polyvascularitis (MPA), and PVtheapproval of the study is based on data from the clinical study Ritux 3The study was a forward-looking, multicenter, random, parallel, open label study in 90 patients with moderate to severe PV diagnosisin thestudy, patients were randomly divided into two programme groups: (1) CS standard dose protocol group; The main endpoint of the study was to achieve complete remission in the 24th month of treatment (defined as complete epitherapy without using steroids for 2 months or more) and without new and/or formed lesions results show that Rituxan significantly increased the rate of PV remission while successfully reducing and/or discontinuing CS therapy The specific data are: 90% of patients in the Rituxan-CS scheme group reached the end point, and only 28% of the CS programme group , Roche is currently conducting another Phase III study of PEMPHIX (NCT02383589) to assess the efficacy and safety of the Rituxan combined dose-reducing CS protocol relative to the immunosuppressive drug Cellcept (McCophenolic acid)
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