Amgen: FDA Approves Amgen's Uplizna As First Drug For Chronic Immune-Mediated Fibroinflammatory Disorder

The U.S. Food and Drug Administration (FDA) on Thursday approved Amgen Inc.'s (NASDAQ:AMGN) Uplizna (inebilizumab-cdon) as the first and only treatment for adult patients with Immunoglobulin G4-related disease (IgG4-RD).IgG4-RD is a chronic immune-mediated fibroinflammatory disorder that often manifests with tumor-like masses and/or painless enlargement of multiple organs. This is the second approved indication for Uplizna, which the FDA previously approved for adult patients with AQP4-IgG+ Neuromyelitis Optica Spectrum Disorder (NMOSD) in June 2020.Also Read: Amgen's Uplizna Shows Improved Symptoms In Patients With Muscle Weakness Disorder Over One YearThe FDA also granted Uplizna Orphan Drug Designation for generalized myasthenia gravis (gMG). Regulatory filing activities are underway for gMG, and submission is anticipated to be completed in H1 2025.The approval is supported by data from the MITIGATE trial. The trial demonstrated the potential of Uplizna to ...Full story available on Benzinga.com