Novartis Achieves Success in Two Phase III Trials for Rare Kidney Diseases, Eyes Regulatory Submissions

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1. Novartis Posts Positive Phase III Results: Novartis has announced successful Phase III trial results for two rare kidney diseases, IgA nephropathy and C3 glomerulopathy, setting the stage for potential regulatory approvals.
2. IgA Nephropathy: The Phase III ALIGN study of atrasentan showed clinically meaningful proteinuria reduction in patients with IgA nephropathy, a heterogeneous and progressive disease affecting approximately 25 people per million worldwide.
3. C3 Glomerulopathy: The Phase III APPEAR-C3G study of Fabhalta (iptacopan) demonstrated a statistically significant 35.1% proteinuria reduction compared to placebo in patients with C3 glomerulopathy.
4. Regulatory Submissions: Novartis plans to submit these treatments for regulatory approval this year, expanding its portfolio in rare kidney diseases.
5. Novartis' Commitment to Renal Health: The company has a long history in nephrology, dating back to the development of cyclosporine, and continues to explore innovative therapeutic options to address unmet needs in rare kidney diseases.