FDA Approves Amgen’s Uplizna for Generalized Myasthenia Gravis in Adults

Reuters12-12

FDA Approves Amgen's Uplizna for Generalized Myasthenia Gravis in Adults

The U.S. Food and Drug Administration (FDA) has approved Amgen Inc.'s 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. This marks the first and only CD19-targeted B cell therapy approved for this patient group, offering a new treatment option with twice-yearly dosing after two initial loading doses. The approval expands UPLIZNA's indications, which already include neuromyelitis optica spectrum disorder (NMOSD) and Immunoglobulin G4-related disease (IgG4-RD).

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Amgen Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: LA45165) on December 11, 2025, and is solely responsible for the information contained therein.

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