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AMGEN PRESENTS POSITIVE PHASE 3 DATA FOR UPLIZNA® (INEBILIZUMAB-CDON) IN GENERALIZED MYASTHENIA GRAVIS (GMG) AT AANEM 2024
AmgenAmgen(US:AMGN) Prnewswire·2024-10-15 12:00

Core Insights - Amgen announced positive top-line results from the Phase 3 MINT trial for UPLIZNA in treating generalized myasthenia gravis (gMG), demonstrating clinically meaningful and statistically significant efficacy [2][3][4] Trial Results - The MINT trial met its primary endpoint with a statistically significant change in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, showing a mean change of -4.2 for UPLIZNA compared to -2.2 for placebo (difference: -1.9, p<0.0001) at Week 26 [3][5] - UPLIZNA also showed significant improvement in Quantitative Myasthenia Gravis (QMG) scores, with a mean change of -4.8 compared to -2.3 for placebo (difference: -2.5, p=0.0002) at Week 26 [5] - The trial included 238 adults, with 190 AChR+ and 48 MuSK+ patients, making it the largest placebo-controlled gMG clinical trial for a biologic therapy [7][9] Safety and Tapering - No new safety signals were identified, and the overall safety profile was consistent with previous data on UPLIZNA [6][7] - Patients on corticosteroids were tapered down to 5 mg of prednisone per day by Week 24, starting at Week 4 [3][10] Future Plans - Amgen plans to file for U.S. approval based on the MINT trial results, with further data expected to characterize the efficacy and safety of UPLIZNA over 12 months [8][9] - UPLIZNA is already approved for neuromyelitis optica spectrum disorder (NMOSD) and has received Breakthrough Therapy Designation for IgG4-Related Diseases [8]