Novartis Q4 Results
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INNOVATION
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Conclusions
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Iptacopan: Ph3 APPEAR study demonstrates clinically meaningful
and statistically significant proteinuria reduction in patients with C3G
Ph2 showed sustained benefits up to 1 year
Primary endpoint
native kidney
24 h UPCR geometric mean
ration to baseline (95% CI)
1.0
0.8-
0.6
0.4
Model estimated geometric mean
ratio to baseline (95% CI) plot of
24 h UPCR (g/mol)
Ph3 met primary endpoint³
.
Clinically meaningful and statistically significant proteinuria
reduction at six-month analysis
Safety profile consistent with previously reported data
.
Simple administration: Oral
Study design
B D 28
D 84
D 354
Visit (days)
Cohort A
16 15
16
15
Blinded treatment
Iptacopan 200mg BID
Primary endpoint
analysis
Open-label treatment
Iptacopan 200mg BID
End of
study
Primary endpoint
transplanted kidney²
Baseline biopsy
Week 12 biopsy
Review results with health authorities for potential submissions in 2024
RH
1:1
N = 74
Placebo
Iptacopan 200mg BID
Day 1
Month 6
Option to
roll-over
Month 12
in OLE
RoE - Roll-over extension. UPCR urine protein creatinine ratio. CI confidence interval. 1. ASN 2022 poster.
2. Kidney biopsy baseline
→ Week 12 C3 Deposit Score. Wong EK, et al. ePoster ASN 2021. 3. December 2023.
□ NOVARTIS | Reimagining Medicine.
Novartis Q4 Results | January 31, 2024
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