Amgen’s UPLIZNA becomes the first FDA-approved treatment for IgG4-related disease

Amgen has announced that the U.S. FDA has approved UPLIZNA (inebilizumab-cdon) as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), a chronic immune-mediated condition. The approval is based on results from the Phase 3b MITIGATE trial, which showed an 87% reduction in the risk of flares versus placebo. UPLIZNA also achieved corticosteroid-free, flare-free, complete remission in over half of treated patients. This marks UPLIZNA’s second approved indication, supporting Amgen’s expanding role in CD19+ B-cell targeted therapies for autoimmune diseases.