Amgen announced positive topline results from its randomized, double-blind, multicenter, placebo-controlled Phase 3 clinical trial evaluating the efficacy and safety of UPLIZNA for the treatment of Immunoglobulin G4-related disease. The trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period. All key secondary endpoints were also met, which were annualized flare rate; flare-free, treatment-free complete remission; and flare-free, corticosteroid-free complete remission. No new safety signals were identified. The overall safety results during the placebo-controlled period of the trial were consistent with the known safety profile of UPLIZNA. Full data from the trial will be presented at a future medical meeting.
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