Efficacy data for FABHALTA^® (iptacopan)

TO REDUCE PROTEINURIA IN ADULTS WITH PRIMARY IgAN AT RISK OF RAPID DISEASE PROGRESSION (UPCR ≥1.5 g/g)¹

Significant reduction in proteinuria at 9 months with FABHALTA¹

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The geometric mean ratio of 24-hour UPCR at baseline was 1.9 g/g for FABHALTA (n=125), 2.0 for placebo (n=125), and 1.0 (n=119) and 1.7 (n=110), respectively, at Month 9.¹

^†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) using an MMRM; Values after taking rescue immunosuppressive treatment for IgAN were imputed to reflect disease worsening. Rescue immunosuppressive treatment for IgAN was initiated in 0 and 7 (5.6%) patients in the FABHALTA and placebo groups up to Month 9, respectively.

FABHALTA delivered sustained reduction in 24-hour UPCR through 9 months¹

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