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Approval was supported by data from the MITIGATE trial, the first randomized, double-blind, placebo-controlled trial conducted in IgG4-RD.
April 4, 2025
By: Charlie Sternberg
Associate Editor
The U.S. Food and Drug Administration (FDA) has approved Amgen’s UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD), a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognizing the high unmet medical need in this serious condition and the medicine’s potential to benefit patients. “The...
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