CDSCO Panel Approves Novartis' Protocol Amendment proposal for Iptacopan Clinical study in Kidney Disorders
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the proposal presented by Novartis Healthcare for protocol amendment of the clinical trial protocol titled "A Phase IIIb clinical trial, an open-label, non-randomized extension study, investigating the long-term efficacy, safety, and tolerability of iptacopan (LNP023) in patients with C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis."
This came after the firm presented protocol amendment version 04 dated 30 Nov 2023 protocol no. CLNP023B12001B.
Iptacopan is an oral medication used to treat paroxysmal nocturnal hemoglobinuria (PNH) and to reduce proteinuria in certain kidney diseases like primary immunoglobulin A nephropathy (IgAN) and complement 3 glomerulopathy (C3G). It works by inhibiting complement factor B, a protein involved in the alternative complement pathway, which is overactive in these conditions.
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