Amgen Inc. (NASDAQ: AMGN) announced that the European Commission (EC) has approved UPLIZNA (inebilizumab) as an add-on therapy for adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) or anti-muscle specific tyrosine kinase (MuSK) antibody positive. The humanized monoclonal antibody, which selectively depletes CD19+ B cells driving autoantibody production, becomes the first biologic approved in Europe with demonstrated efficacy in both AChR+ and MuSK+ subtypes and structured steroid-tapering protocol.
Japan PMDA submission; China NMPA pathway evaluation
2026-2027
Label Expansion
Potential earlier-line use; combination with other immunotherapies
Post-approval
Real-World Evidence
MINT extension studies; patient registry establishment
Ongoing
Forward‑Looking Statements This brief contains forward‑looking statements regarding UPLIZNA European commercial launch, MuSK+ market penetration, and competitive dynamics with efgartigimod and ravulizumab in generalized myasthenia gravis. Actual results may differ due to reimbursement negotiation outcomes, physician adoption of CD19-targeting mechanism, and steroid-tapering protocol implementation challenges.-Fineline Info & Tech
By Fineline Cube 