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The study results demonstrated that Lupkynis combined with mycophenolate mofetil (MMF) and low-dose corticosteroids led to statistically superior complete renal response rates at 52 weeks compared to treatment with MMF and low-dose corticosteroids alone, with a comparable safety profile.
In January this year, the FDA had approved Lupkynis combined with a background immunosuppressive therapy regimen for LN.
AURORA 1 met its primary endpoint, achieving statistically superior complete renal response rates of 41% in the Lupkynis group versus 23% in the control group.
Lupkynis also achieved statistical significance in all pre-specified hierarchical secondary endpoints, including improved time to 50% reduction from baseline in urine protein creatinine ratio (UPCR) or and time to UPCR <0.5 mg/mg compared to control.
Lupkynis was well tolerated with no unexpected safety signals.
Additionally, the Lupkynis group showed no notable decrease at Week 52 in mean eGFR or increase in mean blood pressure, lipids, or glucose, which are common adverse events associated with traditional calcineurin inhibitors.
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