European Commission Approves Amgen's UPLIZNA® for Generalized Myasthenia Gravis

The European Commission has approved Amgen's UPLIZNA® as an add-on treatment for adults with generalized myasthenia gravis (gMG) who are positive for anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibodies. UPLIZNA offers long-term disease control with semi-annual maintenance dosing, following two initial doses.

gMG is a chronic autoimmune disorder that affects muscle strength and quality of life, impacting approximately 56,000-123,000 people in Europe. UPLIZNA is the first approved CD19-targeted therapy in Europe for this condition.

The approval is based on the Myasthenia Gravis Inebilizumab Trial (MINT), showing significant efficacy and reduced steroid use among patients. Key findings demonstrated notable improvements in the MG-ADL and QMG scores. The introduction of UPLIZNA as a treatment option marks an advance in addressing the complex challenges of gMG.