Efficacy data for FABHALTA® (iptacopan)
TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IgAN AT RISK OF RAPID DISEASE PROGRESSION (GENERALLY A UPCR ≥1.5 g/g)1
Significant reduction in proteinuria at 9 months with FABHALTA1
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The geometric mean (GM) of 24-hour UPCR at baseline was 1.9 g/g for FABHALTA (n=125), 2.0 g/g for placebo (n=125), and 1.0 g/g (n=119) and 1.7 g/g (n=110), respectively, at Month 91
No patients in the FABHALTA group initiated rescue immunosuppressive treatment for IgAN up to Month 9, whereas 7 (5.6%) patients in the placebo group did1
38% (95% CI: 26%, 49%) reduction at 9 months relative to baseline in 24-hour UPCR with FABHALTA compared with placebo (P<0.0001)1,†,‡
†One-sided P value statistically significant at the 0.005 level.1
‡Percent reduction in UPCR was obtained from the adjusted GM ratios where the log-transformed ratio to baseline in UPCR (sampled from 24-hour urine collection) was analyzed using an MMRM; values after taking rescue immunosuppressive treatment for IgAN were imputed to reflect disease worsening.1
FABHALTA delivered sustained reduction in 24-hour UPCR through 9 months1
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