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# Amgen: Positive Data on Uplizna in Ig G4 Disease
- URL: https://www.fdaweb.com/amgen-positive-data-on-uplizna-in-ig-g4-disease/
- Published: 2024-06-05T12:00:00.000Z
- Updated: 2026-09-14T14:32:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157123

Amgen is announcing positive topline results from its randomized, placebo-controlled Phase 3 clinical trial ([MITIGATE](https://c212.net/c/link/?t=0&l=en&o=4183672-1&h=1644878285&u=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04540497%3Fcond%3DIgG4-Related%2520Disease%26intr%3DInebilizumab%26rank%3D1%23study-overview&a=NCT04540497&ref=fdaweb.com)) evaluating the efficacy and safety of Uplizna (inebilizumab-cdon) for treating immunoglobulin G4-related disease (IgG4-RD). Currently, the therapy is approved for neuromyelitis optica spectrum disorder.

The company says the trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo. 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, it adds. The overall safety results were also consistent with the therapy’s known safety profile.

Amgen describes IgG4-RD as a chronic, systemic, immune-mediated, fibroinflammatory disease that can affect almost any organ in the body, often involving multiple organs at a time, and can result in irreversible organ damage.

Based on MITIGATE’s data, Amgen says it plans to seek FDA approval for Uplizna’s use in IgG4-RD.