Amgen's Uplizna Shows Improved Symptoms In Patients With Muscle Weakness Disorder Over One Year

On Thursday, Amgen Inc AMGN announced new data from the Phase 3 MINT trial of Uplizna (inebilizumab-cdon) for adult patients with generalized myasthenia gravis (gMG), a chronic autoimmune disease that causes muscle weakness. It affects the muscles used for breathing, swallowing, facial expressions, and movement.

The results demonstrated the durable and sustained efficacy of Uplizna in patients with acetylcholine receptor autoantibody-positive (AChR+) gMG with two doses a year following an initial loading dose.

The trial demonstrated continued improvement in the efficacy of Uplizna compared to placebo as measured by the change in baseline of Myasthenia Gravis Activities of Daily Living (MG-ADL) score in the AChR+ subpopulation through week 52.

Among the AChR+ patients in the Uplizna group, 72.3% had a ≥3-point improvement in the MG-ADL score, compared to 45.2% in placebo.

As previously disclosed at the 2024 American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting, the trial met its primary endpoint, with a statistically significant change from baseline in MG-ADL score for UPLIZNA (-4.2) compared with placebo (-2.2) at Week 26 for the combined study population.

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Change from baseline in the Quantitative Myasthenia Gravis (QMG) score was also greater for patients in the Uplizna group compared to placebo at Week 52.

Among the AChR+ patients in the Uplizna group, 69.2% improved by ≥3 points in the QMG score, compared to 41.8% in the placebo group.1

No new safety signals were identified. The overall TEAE profile during the study period is consistent with the known safety profile for the approved indication.

Uplizna is currently approved for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive neuromyelitis optica spectrum disorder (NMOSD) and is under priority FDA review for the treatment of Immunoglobulin G4-related disease with a PDUFA date of April 3.

The FDA has granted Uplizna Orphan Drug Designation for gMG. Regulatory filing activities are underway with submission anticipated to be complete in H1 2025.

Price Action: AMGN stock is up 1.12% at $315.99 at the last check Thursday.

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