Press release
UPLIZNA® (INEBILIZUMAB-CDON) IS NOW THE FIRST AND ONLY FDA-APPROVED TREATMENT FOR IGG4-RELATED DISEASE
Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo UPLIZNA Shown to Deliver Corticosteroid-Free,
About this update from Amgen Inc.
[{"type":"text","content":"Breakthrough CD19+ B-Cell Targeted Therapy Delivered an 87% Reduction in the Risk of Flares Versus Placebo \nUPLIZNA Shown to Deliver Corticosteroid-Free, Flare-Free, Complete Remission for Patients in the MITIGATE Trial\nAdvances Amgen's Leadership in CD19 Directed, B-Cell Depletion Therapies for Serious Autoimmune Diseases Including NMOSD, IgG4-RD and gMG\nTHOUSAND OAKS, Calif., April 3, 2025 /PRNewswire/ -- Amgen (NASDAQ:AMGN) announced today that the U.S. Food and Drug Administration (FDA) has approved UPLIZNA as the first and only treatment for adults living with Immunoglobulin G4-related disease (IgG4-RD). IgG4-RD is a chronic and debilitating immune-mediated inflammatory condition that can affect multiple organs. The FDA granted Breakthrough Therapy Designation to UPLIZNA for the treatment of IgG4-RD, recognizing the high unmet medical need in this serious condition and the medicine's potential to benefit patients.\n\"The FDA approval of UPLIZNA marks a significant turning point for IgG4-RD patients and physicians who now have a proven treatment that targets a key driver of the disease, reducing the risk of flares and reliance on harmful long-term steroid use,\" said Jay Bradner, M.D., executive vice president of Research and Development at Amgen. \"We are proud to deliver a therapy that has the potential to significantly improve care for patients with IgG4-RD and remain encouraged by UPLIZNA's broader potential in other immune-mediated diseases, including neuromyelitis optica spectrum disorder and generalized myasthenia gravis. This approval underscores Amgen's ongoing commitment and leadership in developing innovative treatments targeting CD19+ B-cells across multiple therapeutic areas.\"\nIgG4-RD can occur in multiple organs and lead to fibrosis and permanent organ damage.1,2 Understanding how organ damage manifests is critically important to inform the timely diagnosis of IgG4-RD. The disease mimics other diseases due to the heterogeneous and unpredictable inflammatory flares that can occur.3 Over time, IgG4-RD can affect virtually any organ system.1\n\"Targeting CD19+ B cells with UPLIZNA has proven to be a highly effective approach to help address the pathophysiology of IgG4-RD,\" said John Stone, M.D., M.P.H., principal investigator, and a professor of medicine at Harvard Medical School and the Edward A. Fox Chair ...