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# Amgen Seeking Expanded Uplizna Use
- URL: https://www.fdaweb.com/amgen-seeking-expanded-uplizna-use/
- Published: 2025-03-13T12:00:00.000Z
- Updated: 2026-09-14T14:55:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158816

Amgen says it will file a BLA supplement by 6/30 for Uplizna (inebilizumab-cdon) to expand its use to treat adults living with generalized myasthenia gravis (gMG). The submission will be based on just-reported data from the Phase 3 MINT trial, demonstrating “durable and sustained efficacy of Uplizna in patients with acetylcholine receptor autoantibody-positive (AChR+) gMG with two doses a year,” the company says.

The therapy is currently approved for treating adult patients with anti-aquaporin-4 antibody positive neuromyelitis optica spectrum disorder. It is currently under priority FDA review for treating immunoglobulin G4-related disease, with a user fee review action target date of 4/3.