Amgen's UPLIZNA® Approved by European Commission for Generalized Myasthenia Gravis

First and Only CD19-Targeted Therapy Approved in Europe for Adults with anti-AChR+ and anti-MuSK+ gMG

Feb. 12, 2026 at 7:07pm

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The European Commission has approved Amgen's UPLIZNA® (inebilizumab) as an add-on treatment to standard therapy for adults living with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. The 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.

Why it matters

Generalized myasthenia gravis is a rare, unpredictable, chronic, B-cell-mediated autoimmune disease that causes fluctuating muscle weakness and can impact quality of life. 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.

The details

UPLIZNA is a humanized monoclonal antibody that causes targeted and sustained depletion of key cells that contribute to the underlying disease process (autoantibody-producing CD19+ B cells, including plasmablasts and some plasma cells). The approval is supported by data from the Myasthenia Gravis Inebilizumab Trial (MINT), the largest Phase 3 biologic study to include both AChR+ and MuSK+ patients, and the first to successfully incorporate a structured steroid-tapering protocol.

  • UPLIZNA was previously approved as a monotherapy for adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive in November 2025.
  • The European Commission approval for UPLIZNA in generalized myasthenia gravis was announced on February 12, 2026.

The players

Amgen

An American multinational biopharmaceutical company that discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases.

UPLIZNA

A humanized monoclonal antibody that causes targeted and sustained depletion of key cells that contribute to the underlying disease process in generalized myasthenia gravis.

Cesar Sanz Rodriguez

Vice president of Medical Affairs at Amgen.

John Vissing

Professor of neurology and director of the Copenhagen Neuromuscular Center, Rigshospitalet, at the University of Copenhagen.

Myasthenia Gravis Inebilizumab Trial (MINT)

A randomized, double-blind, placebo-controlled, parallel-group trial designed to evaluate the efficacy and safety of UPLIZNA in adults with generalized myasthenia gravis.

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What they’re saying

“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.”

— Cesar Sanz Rodriguez, Vice president of Medical Affairs at Amgen

“UPLIZNA offers a new approach to treating gMG by selectively targeting CD19-positive B cells, which play a key role in disease pathology. 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.”

— John Vissing, Professor of neurology and director of the Copenhagen Neuromuscular Center, Rigshospitalet, at the University of Copenhagen

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