UPLIZNA® (INEBILIZUMAB-CDON) IS NOW THE FIRST AND ONLY FDA-APPROVED TREATMENT FOR IGG4-RELATED DISEASE

Core Insights - Amgen's UPLIZNA has received FDA approval as the first and only treatment for adults with Immunoglobulin G4-related disease (IgG4-RD), addressing a significant unmet medical need in this chronic and debilitating condition [1][2][8] Company Developments - The approval of UPLIZNA is a pivotal moment for patients and healthcare providers, offering a proven treatment that targets a key driver of IgG4-RD, thereby reducing the risk of flares and reliance on long-term steroid use [2][3] - UPLIZNA's efficacy is supported by data from the MITIGATE trial, which demonstrated an 87% reduction in the risk of IgG4-RD flares compared to placebo [9] - UPLIZNA is also indicated for the treatment of AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) and has received Orphan Drug Designation for generalized myasthenia gravis (gMG), with regulatory filings for gMG expected to be completed in H1 2025 [1][8] Clinical Trial Insights - The MITIGATE trial was the first randomized, double-blind, placebo-controlled trial for IgG4-RD, showing significant reductions in disease activity and flares among patients treated with UPLIZNA [4][5] - Key findings from the trial include that 57.4% of UPLIZNA-treated participants achieved flare-free, treatment-free, and complete remission at Week 52, compared to 22.4% in the placebo group [9] - UPLIZNA-treated patients experienced a ten-fold reduction in mean total glucocorticoid use for disease control compared to those on placebo [9] Disease Background - IgG4-RD is a chronic, systemic, immune-mediated disease that can affect multiple organs and lead to fibrosis and permanent organ damage [6] - The disease is characterized by unpredictable inflammatory flares and can mimic other conditions, complicating timely diagnosis [6][7] - The prevalence of IgG4-RD is estimated at 20,000 people in the U.S., with a higher incidence in men and typical onset between ages 50 and 70 [6]