Press release
FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS
UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing*First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and
About this update from Amgen Inc.
[{"type":"text","content":"UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing*First and Only CD19-Targeted B Cell Therapy Approved in anti-AChR and anti-MuSK Ab+ gMGTHOUSAND OAKS, Calif., Dec. 11, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA® (inebilizumab-cdon) for the treatment of generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) and anti-muscle specific tyrosine kinase (MuSK) antibody positive. The approval offers patients a new targeted treatment option that has the potential for long-term disease control with just two doses a year, after two initial loading doses.\"This approval marks a significant advancement for people living with gMG,\" said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. \"By selectively targeting CD19-positive B cells, UPLIZNA offers a new approach to treatment that addresses a biological root cause of disease. UPLIZNA is conveniently dosed twice a year and delivers durable efficacy, helping people manage debilitating symptoms that can compromise daily function – including trouble breathing, speaking and seeing.\"gMG is a rare, unpredictable, chronic, B-cell-mediated autoimmune disorder that impairs neuromuscular communication and can cause fluctuating muscle weakness.1-3 The disease is thought to be primarily driven by AChR and MuSK autoantibodies, which are produced by CD19+ B cells, particularly plasmablasts and some plasma cells.1-3 Myasthenia gravis impacts approximately 80,000 to 100,000 people in the U.S.4,5The approval of UPLIZNA for gMG is supported by data from the Myasthenia Gravis Inebilizumab Trial (MINT), the largest Phase 3 biologic study to include both AChR+ and MuSK+ patients, and the first to successfully incorporate a steroid taper into its protocol. Patients on steroids at baseline began tapering at Week 4 to reach prednisone 5 mg per day by Week 24. By Week 26, 87.4% of patients taking UPLIZNA and 84.6% of those taking placebo had reduced their steroid dose to 5 mg or less per day.6 \"UPLIZNA showed strong efficacy at 26 weeks in both AChR+ and MuSK+ patients, with AChR+ patients continuing to improve through 52 weeks in MINT,\" said Richard J. Nowak, M.D., M.S., global principal investigator and director of the Myastheni...