FDA Approves Amgen's UPLIZNA For Adults With Generalized Myasthenia Gravis

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(RTTNews) - Amgen (AMGN) announced that the U.S. Food and Drug Administration has approved UPLIZNA (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive.

The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses.

gMG is a rare, unpredictable, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause fluctuating muscle weakness. The disease is thought to be primarily driven by AChR and MuSK autoantibodies, which are produced by CD19+ B cells, particularly plasmablasts and some plasma cells. Myasthenia gravis impacts approximately 80,000 to 100,000 people in the U.S.

This marks the third FDA-approved indication for UPLIZNA, which was previously authorized for adult patients with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) in June 2020, and for adult patients with Immunoglobulin G4-related disease (IgG4-RD) in April 2025.

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