Amgen(AMGN) Prnewswire·2025-03-13 13:00Core Insights - Amgen announced new data from the Phase 3 MINT trial showing the efficacy and safety of UPLIZNA in adults with generalized myasthenia gravis (gMG), indicating durable symptom relief with a simplified treatment regimen of two doses per year after an initial loading dose [1][3] Group 1: Trial Results - The MINT trial demonstrated significant improvement in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score for UPLIZNA compared to placebo, with an adjusted difference of -2.8 (95% CI, -3.9 to -1.7) in the AChR+ subpopulation at week 52 [2] - Among AChR+ patients treated with UPLIZNA, 72.3% experienced a ≥3 point improvement in the MG-ADL score, compared to 45.2% in the placebo group [2] - The trial also showed a greater change from baseline in the Quantitative Myasthenia Gravis (QMG) score for UPLIZNA patients at week 52, with an adjusted difference of -4.3 (95% CI, -5.9 to -2.8) [3] Group 2: Treatment Protocol - The MINT trial was notable for incorporating a corticosteroid tapering protocol, where patients on corticosteroids were reduced to prednisone 5 mg per day by week 24 [3][10] - UPLIZNA is administered as an initial loading dose followed by maintenance doses every six months, which simplifies the treatment regimen for patients [12] Group 3: Regulatory Status - UPLIZNA is currently approved for treating adult patients with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD) and is under priority FDA review for Immunoglobulin G4-related disease (IgG4-RD) with a PDUFA date of April 3, 2025 [5] - The FDA has granted UPLIZNA Orphan Drug Designation for the treatment of gMG, with regulatory filing activities expected to be completed in the first half of 2025 [5] Group 4: Safety Profile - No new safety signals were identified during the MINT trial, and the overall treatment-emergent adverse event (TEAE) profile was consistent with the known safety profile for UPLIZNA [4] - The most common adverse events reported included infusion-related reactions, nasopharyngitis, and urinary tract infections [4][15]