Amgen’s Uplizna shows potential efficacy in rare inflammatory diseases

Amgen (AMGN) announced the presentation of new data across its rare disease portfolio and pipeline at the annual American College of Rheumatology – ACR – 2024 conference in Washington, D.C., Nov. 14-19. New data showcase reduction in disease activity by Uplizna in Immunoglobulin G4-Related Disease and support shorter infusion times for Krystexxa co-administered with weekly oral methotrexate 15 mg. Key findings from the presentations include: a clinically meaningful and statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo during the 52-week placebo-controlled period; seven of 68 participants receiving Uplizna experienced a flare compared to 40 of 67 participants receiving placebo; 57.4% of participants receiving Uplizna achieved flare-free, treatment-free, complete remission at Week 52 vs. 22.4% participants receiving placebo; 89.7% of Uplizna -treated patients required no glucocorticoid treatment for disease control during the placebo-controlled period vs. 37.3% of patients on placebo. Safety results in the placebo-controlled period were consistent with the established safety profile of Uplizna. The data were simultaneously published in the New England Journal of Medicine. 67.2% of participants receiving a 60-minute infusion duration of Krystexxa with methotrexate achieved and maintained a response during Month 6. In August, the FDA granted Breakthrough Therapy Designation for Uplizna in IgG4-RD and regulatory filing activities are currently underway.