Amgen Reports Positive Data From Phase 3 MINT Study Of Uplizna In Generalized Myasthenia Gravis

(RTTNews) - Amgen Inc. (AMGN) Thursday announced positive data from the Phase 3 MINT study of Uplizna in adults with generalized myasthenia gravis (gMG).

Myasthenia gravis is a chronic autoimmune disorder that causes weakness in the voluntary muscles.

The Phase 3 MINT study is designed to evaluate Uplizna in muscle-specific kinase autoantibody-positive (MuSK+) and acetylcholine receptor autoantibody-positive (AChR+) gMG patients, with the MuSK+ group followed for 26 weeks and the AChR+ group followed for 52 weeks. Results from the study demonstrated durable and sustained efficacy of Uplizna in AChR+ gMG patients with two doses a year, following an initial loading dose.

These data are to be presented at the American Academy of Neurology (AAN) Annual Meeting on April 8, 2025, in San Diego.

Uplizna is currently approved for the treatment of Neuromyelitis Optica Spectrum Disorder (NMOSD). The drug is also under priority FDA review for the treatment of Immunoglobulin G4-related disease (IgG4-RD) with a PDUFA date of April 3, 2025.