Amgen’s Uplizna Achieves Phase 3 Success in Treating Immunoglobulin G4-Related Disease, Paving Way for Label Expansion

1. Phase 3 Success: Amgen's Uplizna has met its primary endpoint in a Phase 3 study, demonstrating an 87% reduction in the risk of flares in patients with Immunoglobulin G4-Related Disease (IgG4-RD) compared to placebo.
2. Rare Autoimmune Disease: IgG4-RD is a chronic, immune-mediated disease that can affect multiple organs and cause irreversible damage. It currently has no approved therapies.
3. Label Expansion: Based on the positive results, Amgen plans to file for U.S. FDA approval of Uplizna in IgG4-RD, followed by other key markets.
4. Current Indication: Uplizna is currently approved for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in several regions.
5. Acquisition History: Uplizna was acquired by Amgen as part of its $27.8 billion purchase of Horizon Therapeutics, which had previously acquired the drug from Viela Bio.
6. Future Studies: Amgen is also investigating Uplizna in myasthenia gravis, with a Phase 3 readout expected in the second half of 2024.