JHVEPhoto/iStock Editorial via Getty Images 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.
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