WS Investor
13 Feb 2026, 20:01
Amgen announced that the European Commission has approved UPLIZNA® (inebilizumab) as an add-on treatment for adults with generalized myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive. It is the first and only CD19-targeted therapy approved in Europe for these patients.
The approval is based on the Phase 3 MINT trial, which showed a statistically significant improvement in MG-ADL and QMG scores at Week 26 versus placebo. UPLIZNA delivered a 1.9-point greater reduction in MG-ADL scores (p<0.0001) and a 2.5-point greater reduction in QMG scores (p=0.0002) in the combined population. The therapy is administered after two initial infusions, followed by maintenance dosing every six months.
gMG is a rare, chronic autoimmune disease that causes fluctuating muscle weakness and can severely impact daily functioning. The approval expands UPLIZNA’s European indications, which already include IgG4-related disease and neuromyelitis optica spectrum disorder.
PR Newswire
The approval is based on the Phase 3 MINT trial, which showed a statistically significant improvement in MG-ADL and QMG scores at Week 26 versus placebo. UPLIZNA delivered a 1.9-point greater reduction in MG-ADL scores (p<0.0001) and a 2.5-point greater reduction in QMG scores (p=0.0002) in the combined population. The therapy is administered after two initial infusions, followed by maintenance dosing every six months.
gMG is a rare, chronic autoimmune disease that causes fluctuating muscle weakness and can severely impact daily functioning. The approval expands UPLIZNA’s European indications, which already include IgG4-related disease and neuromyelitis optica spectrum disorder.
PR Newswire
