Uplizna approved for generalised Myasthenia Gravis

Amgen has recently announced that the EC has approved UPLIZNA as an add-on treatment to standard therapy for adults living with generalized myasthenia gravis who are anti-acetylcholine receptor or anti-muscle specific tyrosine kinase antibody positive. This approval offers patients a new, targeted treatment option with the potential for long-term disease control through twice-yearly maintenance dosing, following two initial loading doses.

Note that generalized myasthenia gravis is a rare, unpredictable, chronic, B-cell-mediated autoimmune disease that causes fluctuating muscle weakness and can impact quality of life.1-3 It is a subtype of myasthenia gravis, which affects an estimated 56,000-123,000 people in Europe.

“This approval represents an important advancement for adults with gMG in Europe, helping address debilitating symptoms and potentially reduce the long-term use of steroids where clinically appropriate,” said Cesar Sanz Rodriguez, vice president of Medical Affairs at Amgen. “With convenient twice-yearly dosing and durable efficacy in people with anti‑AChR and anti‑MuSK antibody positive gMG, UPLIZNA brings a new first-in-class approach to managing this complex disease.”

“UPLIZNA offers a new approach to treating gMG by selectively targeting CD19-positive B cells, which play a key role in disease pathology,” said John Vissing, MD, DMSci, professor of neurology and director of the Copenhagen Neuromuscular Center, Rigshospitalet, at the University of Copenhagen. “The approval provides both clinicians and patients a valuable new treatment option with the potential for long-term efficacy while addressing the challenges of long-term steroid exposure.”

In addition, the approval in gMG builds on UPLIZNA’s established efficacy in rare autoimmune conditions, including its November 2025 EC approval as the first and only treatment for adults living with active immunoglobulin G4-related disease, a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs.

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Related Topics and Keywords

Amgen, generalised myasthenia gravis, uplizna