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News about "Vanrafia"
Fabhalta from Novartis Meets Phase-III Goal in Slowing Kidney Decline in IgAN Patients
Fabhalta (iptacopan) from Novartis met its Phase III primary endpoint, slowing kidney function decline in IgA nephropathy (IgAN) patients. The first approved complement inhibitor for IgAN, Fabhalta builds on its 2024 U.S. accelerated approval, with data supporting a 2026 traditional FDA submission.
Vanrafia | 17/10/2025 | By Dineshwori
Novartis Gets FDA Accelerated Approval for Vanrafia
Vanrafia was granted accelerated approval based on a prespecified interim analysis of the Phase III ALIGN study measuring the reduction of proteinuria at 36 weeks compared to placebo1. It has not been established whether Vanrafia slows kidney function decline in patients with IgAN.
Vanrafia | 03/04/2025 | By Aishwarya | 214
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