Exceptional top-line Phase III results for Uplizna in IgG4-RD
Top-line data from the randomized, placebo-controlled Phase III MITIGATE study demonstrated Uplizna (inebilizumab) met all primary and key secondary endpoints in treating immunoglobulin G4-related disease (IgG4-RD), US biotech major Amgen (Nasdaq: AMGN) announced today.
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. No new safety signals were identified. The overall safety results during the placebo-controlled period of the trial were consistent with the known safety profile of inebilizumab. Full data from the trial will be presented at a future medical meeting.
Uplizna is currently approved for neuromyelitis optica spectrum disorder (NMOSD) by several regulatory bodies, including the US Food and Drug Administration, the European Medicines Agency, Health Canada and the Brazilian Health Regulatory Agency (ANVISA), among others.
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