Biopharmaceutical company Amgen (NASDAQ:AMGN) on Thursday announced new data from its Phase 3 MINT trial, demonstrating that UPLIZNA (inebilizumab-cdon) significantly improves symptoms in patients with acetylcholine receptor autoantibody-positive (AChR+) generalised myasthenia gravis (gMG).

Patients receiving twice-yearly doses (following an initial loading dose) reported sustained symptom relief and improved ability to perform daily activities over 52 weeks.

The randomised controlled trial showed a statistically significant improvement in Myasthenia Gravis Activities of Daily Living (MG-ADL) scores for AChR+ patients treated with UPLIZNA compared to placebo. At Week 52, 72.3% of AChR+ patients in the UPLIZNA group improved by at least three points, versus 45.2% in the placebo group. The treatment also led to a greater reduction in Quantitative Myasthenia Gravis (QMG) scores, with 69.2% of patients improving by at least three points compared to 41.8% on placebo.

MINT was the first Phase 3 biologic trial to incorporate a corticosteroid taper, with patients reducing steroid use by Week 24. The findings will be presented as a late-breaking oral presentation at the American Academy of Neurology Annual Meeting on 8 April 2025.

UPLIZNA is already approved for neuromyelitis optica spectrum disorder and is under priority FDA review for Immunoglobulin G4-related disease, with a decision expected by 3 April 2025. Amgen is preparing regulatory filings for gMG, with submission anticipated in the first half of 2025.