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news.Amgen has secured approval from the European Commission (EC) for Uplizna (inebilizumab) as an add-on treatment to standard therapy for adults with generalised myasthenia gravis (gMG) who are anti-acetylcholine receptor or anti-muscle-specific tyrosine kinase antibody positive.
MINT enrolled 238 adults with gMG, including 190 AChR+ and 48 MuSK+ patients. Credit: luchschenF / Shutterstock.com.
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This approval provides a new option for long-term disease control in patients, with twice-yearly maintenance dosing after two initial loading doses.
gMG is a rare, chronic, B-cell-mediated autoimmune condition resulting in fluctuating muscle weakness and affecting quality of life.
The decision by the EC was supported by data from the Myasthenia Gravis Inebilizumab Trial (MINT).
This is the largest Phase III biologic study to include both acetylcholine receptor-positive (AChR+) and muscle-specific tyrosine kinase-positive (MuSK+) patients, as well as the first to incorporate a structured steroid-tapering protocol.
In the trial, patients receiving steroids at baseline began tapering at week four, aiming for prednisone 5mg per day by week 24. By week 26, 87.4% of patients on Uplizna and 84.6% on placebo reduced their steroid dose to 5mg or less per day.
MINT enrolled 238 adults with gMG, including 190 AChR+ and 48 MuSK+ patients. Criteria included Myasthenia Gravis Foundation of America (MGFA) classification of II–IV, myasthenia gravis activities of daily living (MG-ADL) score requirements, and stable steroid/immunosuppressive therapy at randomisation.
Uplizna previously received EC approval for active immunoglobulin G4-related disease in November 2025 and is also approved as a monotherapy for neuromyelitis optica spectrum disorder in adults who are aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.
Amgen medical affairs vice-president Cesar Sanz Rodriguez said: “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.
“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.”
In September 2025, Amgen revealed a significant investment plan, earmarking $650m to enhance its manufacturing operations in the US.
