Amgen Reports Positive Phase 3 Data For Uplizna In Generalized Myasthenia Gravis

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(RTTNews) - Amgen Inc. (AMGN) Tuesday announced positive topline data from the Phase 3 MINT study evaluating Uplizna for the treatment of adults with generalized myasthenia gravis, a rare autoimmune disorder. The study met its primary goal.

The primary endpoint of the study was change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score, which assesses how myasthenia gravis symptoms affect daily activities. The study included patients who are acetylcholine receptor autoantibody-positive (AChR+) and those who are muscle-specific kinase autoantibody-positive (MuSK+). The antibodies acetylcholine receptor and muscle-specific kinase can be found in the blood of people with myasthenia gravis.

Results from the study showed that Uplizna demonstrated clinically meaningful and statistically significant efficacy in both AChR+ and MuSK+ patients.

These results will be presented at the Myasthenia Gravis Foundation of America (MGFA) Scientific Session during the American Association of Neuromuscular & Electrodiagnostic Medicine (AANEM) Annual Meeting, taking place October 15-18 in Savannah, Georgia.

Uplizna is already approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease of the central nervous system.