Amgen’s Uplizna Achieves Success in Phase 3 Trial for Immunoglobulin G4-Related Disease (IgG4-RD)

1. Positive Phase 3 Results: Amgen's Uplizna (inebilizumab-cdon) has demonstrated positive results in a Phase 3 trial for the treatment of Immunoglobulin G4-Related Disease (IgG4-RD), a rare autoimmune condition.
2. 87% Risk Reduction: The trial showed an 87% reduction in IgG4-RD flares compared to placebo, with all significant secondary endpoints also met.
3. Current Indications: Uplizna is currently approved for Neuromyelitis Optica Spectrum Disorder (NMOSD) by regulatory bodies including the U.S. FDA, EMA, Health Canada, and ANVISA.
4. Acquisition: Amgen acquired Uplizna through its $27.8 billion purchase of Horizon Therapeutics, with sales of $80 million in the first quarter of 2024.
5. Future Filings: Amgen plans to file for U.S. approval and expand to key international markets based on the trial's results.
6. Safety Profile: The trial did not reveal any new safety concerns, aligning with Uplizna's established safety profile.
7. Steroid-Sparing Approach: The study's design offers a less toxic treatment approach, which could be beneficial for patients.