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The approval was based on data from three phase 3 trials that evaluated the efficacy and safety of upadacitinib in patients 12 years of age and older with moderate to severe atopic dermatitis who are candidates for systemic therapy.
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The updated labeling is based on results from a safety management cohort from the ZUMA-1 study.
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The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
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Tezspire is a first-in-class human monoclonal antibody that works by blocking thymic stromal lymphopoietin, an epithelial cytokine involved in the initiation and persistence of airway inflammation.
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In a study, the calcineurin inhibitor tacrolimus proved to be noninferior to intravenous cyclophosphamide.
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The approval was based on data from the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.
