Amgen has received European Commission approval for Uplizna (inebilizumab) as an add-on to standard therapy in adult patients with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (anti-AChR) or anti-muscle-specific tyrosine kinase (anti-MuSK) antibodies.[1] Uplizna is the first and only CD19-targeted therapy approved in Europe for adults with anti-AChR+ and anti-MuSK+ gMG.[1] Treatment offers the possibility of long-term disease control with twice-yearly dosing after two initial booster doses.[1] The approval is based on the results of the phase III MINT clinical trial, where Uplizna showed a significant change in QMG score (-4.8) in the overall population.[5] In the MINT study, 87.4% of patients taking Uplizna reduced their steroid dose to 5 mg or less per day by week 26.[2] Upliza targets CD19-expressing B-cells that produce disease-causing antibodies.[1][3] This is the third indication for Uplizna, which was previously approved for neuromyelitic optic spectrum disorder (NMOSD) and IgG4-related disease.[1][4] The most commonly reported adverse effects include headache and infusion-related reactions.[2]