Novartis Q4 Results
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Iptacopan and atrasentan: Positive Ph3 readouts demonstrating
clinically meaningful proteinuria reduction in IgAN
INNOVATION
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Company overview
Financial review
Assets
Conclusions
Positive clinically meaningful IA1 (primary endpoint)
2021
2022
2023
2024
2025
2026+ Comments
Iptacopan
Ph3 - APPLAUSE
*
Positive clinically meaningful IA1 (primary endpoint)
Ph3 - BEYOND²
UPCR submission-enabling readout expected 2026
References
Atrasentan
Ph3 - ALIGN
*
Appendix
Zigakibart
* US submission for accelerated approval
Iptacopan and atrasentan FDA submissions expected in H1 2024, based on proteinuria reduction
Studies continue to confirmatory endpoint (eGFR) in 2025
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UPCR urine protein creatinine ratio. 1. October 2023, 9 months readout may support US submission for accelerated approval. 2. Global, randomized, multicenter, double-blind, placebo-controlled Ph3 comparing safety and efficacy of
zigakibart (600mg Q2W) vs. placebo in patients (N-272) with IgAN at risk of progressive loss of kidney function.
□ NOVARTIS | Reimagining Medicine.
Novartis Q4 Results | January 31, 2024
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