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The FDA approved only the five-mg, twice-daily dose on the grounds that a higher dose was not considered to have an adequate risk-to-benefit ratio. [34] In September 2020, the FDA approved tofacitinib for the treatment of children and adolescents two years of age and older with active polyarticular course juvenile idiopathic arthritis. [35]
Pfizer Announces FDA Acceptance for Review of Application to Expand Labeling for XELJANZ ® (tofacitinib citrate) for Adults with Moderately to Severely Active Rheumatoid Arthritis to Include ...
This list of over 500 monoclonal antibodies includes approved and investigational drugs as well as drugs that have been withdrawn from market; consequently, the column Use does not necessarily indicate clinical usage. See the list of FDA-approved therapeutic monoclonal antibodies in the monoclonal antibody therapy page.
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The first JAK inhibitor approved for the treatment of rheumatoid arthritis was tofacitinib. It has also shown promising results in other autoimmune disorders. [13] [1] Initially, tofacitinib was thought to be a selective JAK3 inhibitor, but later was found to be a potent inhibitor of JAK1 and JAK2. [2]
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