First and Only CD19-Targeted Therapy Approved in Europe for Adults with anti-AChR+ and anti-MuSK+ gMG
UPLIZNA Demonstrates Durable Disease Control with Twice-Yearly Dosing*
Amgen (NASDAQ:AMGN) today announced the European Commission (EC) has approved 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.
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 (MG), which affects an estimated 56,000-123,000 people in Europe.4
“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.”
The EC 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. Patients receiving steroids at baseline began tapering at Week 4 with a goal of reaching prednisone 5 mg per day by Week 24. By Week 26, 87.4% of patients taking UPLIZNA and 84.6% of those taking placebo had reduced their steroid dose to 5 mg or less per day.5
“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.”
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 (IgG4-RD),6 a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs.7,8 UPLIZNA was also previously approved as a monotherapy for adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive.6
UPLIZNA has received regulatory approvals across multiple indications from the U.S. Food and Drug Administration, Health Canada, and the Brazilian Health Regulatory Agency (ANVISA), among others.
