Amgen 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.
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), a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. UPLIZNA was also previously approved as a monotherapy for adult patients with neuromyelitis oica spectrum disorder (NMOSD) who are anti-aquaporin-4 immunoglobulin G (AQP4-IgG) seropositive. 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.
