US EditionFDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS
UPLIZNA offers twice-yearly dosing and showed a 1.9-point improvement in daily living activities for adults with antibody-positive generalized myasthenia gravis in the Phase 3 MINT trial.
- Amgen announced that the FDA expanded UPLIZNA's indication on Dec. 11, 2025, to treat adults with antibody-positive generalized myasthenia gravis, listing the new use in UPLIZNA's U.S. labeling from Thousand Oaks, California.
- Because gMG is driven by CD19-positive B cells, it involves autoantibodies against AChR and MuSK produced by these cells, and UPLIZNA depletes CD19+ B cells to target the disease.
- The Phase 3 Myasthenia Gravis Inebilizumab Trial enrolled 238 adults including 190 AChR+ and 48 MuSK+ patients, showing a 1.9-point MG-ADL improvement at Week 26 and sustained 2.8-point benefit through Week 52 with steroid tapering.
- Clinically, UPLIZNA is given as two initial infusions followed by one dose every six months, enabling steroid tapering but requiring HBV, tuberculosis, and immunoglobulin monitoring due to headache and infusion-related reactions.
- Looking at broader implications, the FDA approved UPLIZNA as the first-and-only CD19-targeted B-cell therapy for AChR+ and MuSK+ gMG, with post-market infection risks associated with UPLIZNA.
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MedPage Today
Anti-Aging, Acupuncture and Health NewsMyasthenia Gravis Gets a New Drug Approval
(MedPage Today) -- The FDA expanded the indication of inebilizumab (Uplizna) to include generalized myasthenia gravis (gMG), Amgen announced Friday. The drug is now approved to treat gMG in adults who are anti-acetylcholine receptor (AChR) or...
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FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS
UPLIZNA Offers gMG Patients Deep and Durable Symptom Control and Twice-Yearly Dosing*
FDA APPROVES UPLIZNA® FOR ADULTS WITH GENERALIZED MYASTHENIA GRAVIS - PressReach
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+ gMG THOUSAND 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 re…
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