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# Amgen’s Uplizna OK’d for Generalized Myasthenia Gravis
- URL: https://www.fdaweb.com/amgens-uplizna-okd-for-generalized-myasthenia-gravis/
- Published: 2025-12-12T12:00:00.000Z
- Updated: 2026-09-14T15:29:05.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5160377

FDA has approved Amgen’s Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) or anti-MuSK antibodies, giving patients a new twice-yearly biologic option aimed at sustained disease control.

Uplizna, already approved for treating neuromyelitis optica spectrum disorder (NMOSD) and IgG4-related disease, is now the first therapy targeting CD19-positive B cells approved for this segment of the gMG population. The company says by depleting a broad set of B-cell subsets, including plasmablasts and some plasma cells, the drug addresses an upstream

Approval was based on results from the Phase 3 Myasthenia Gravis Inebilizumab Trial (MINT), a 238-patient randomized, placebo-controlled study that enrolled both antibody-positive subgroups. MINT is also the first successful Phase 3 gMG trial to incorporate a structured steroid taper, according to the company.

By Week 26, 87.4% of patients receiving Uplizna and 84.6% of placebo recipients had reduced their prednisone dose to 5 mg or less per day, Amgen says. Treatment with Uplizna also led to a 1.9-point improvement over placebo in the Myasthenia Gravis Activities of Daily Living score (-4.2 vs. -2.2). In AChR+ patients, Amgen reports that improvements deepened through Week 52, with an exploratory analysis showing a 2.8-point benefit over placebo.