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Amgen Seeks Expanded US Approval For Autoimmune Disease Drug Acquired Via $28B Horizon Deal

On Wednesday, Amgen Inc (NASDAQ:AMGN) announced topline results from its Phase 3 trial evaluating the efficacy and safety of Uplizna (inebilizumab-cdon) for Immunoglobulin G4-related disease, a systemic autoimmune fibroinflammatory multiorgan disease, usually involving the pancreas. Amgen added Uplizna via a $27.8 billion acquisition of Horizon Therapeutics and recorded sales of $80 million in the first quarter of 2024. The trial met its primary endpoint, showing a statistically significant 87% reduction in the risk of IgG4-RD flare compared to placebo (Hazard Ratio 0.13, p<0.0001) during the 52-week placebo-controlled period. All key secondary endpoints were also met, which ...