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Amgen (NASDAQ:AMGN) announced Wednesday that its FDA-approved therapy, Uplizna, reached its main goal in a Phase 3 registrational trial for patients with immunoglobulin G4-related disease (IgG4-RD), an immune-mediated multi-organ disorder.
Based on topline data from its 135-patient MITIGATE trial, the Thousand Oaks, California-based pharma giant said that Uplizna cut the risk of IgG4-RD flare, the study’s primary endpoint, by 87% with a statistically significant effect compared to placebo.
Citing 52-week data, the company also said MITIGATE met all key secondary endpoints, and the study drug was not linked to any new safety events.
Uplizna, also known as inebilizumab-cdon, is approved in the U.S. and other countries for the central nervous system disease, neuromyelitis optica spectrum disorder (NMOSD).
Amgen (AMGN) conducted the trial in partnership with Japanese pharmaceutical company Mitsubishi Tanabe Pharma and Chinese biopharma Hansoh Pharmaceutical (OTCPK:HNSPF).
Based on MITIGATE data, the company intends to file for a label expansion of Uplizna in the U.S., followed by other markets.
