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The Food and Drug Administration (FDA) has approved Saphnelo (anifrolumab-fnia) for the treatment of adults with moderate to severe systemic lupus erythematosus who are receiving standard therapy. Type I interferons (IFNs) play a role in the pathogenesis of systemic lupus erythematosus (SLE). Anifrolumab-fnia, a human immunoglobulin G1 kappa monoclonal antibody, binds to subunit 1 of…
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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 the phase 3 JADE clinical trial program, which included the JADE MONO-1, JADE MONO-2, and JADE COMPARE trials.
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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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Zolgensma is an adeno-associated virus vector-based gene therapy.
