Novartis Healthcare gets CDSCO Panel nod to study Iptacopan
New Delhi: The drug major Novartis Healthcare has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the extension part of the study to evaluate the long-term efficacy, safety, and tolerability of iptacopan (LNP023) in C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis.
This came after Novartis Healthcare presented phase IIIb clinical study protocol no. CLNP023B12001B, version 03 dated 25 July 2022. This is an An open-label, non-randomized extension study to evaluate the long-term efficacy, safety, and tolerability of iptacopan (LNP023) in C3 glomerulopathy or idiopathic immune-complex-membranoproliferative glomerulonephritis.
The firm also presented unblinded data for CLNP023B12301 APPEAR-C3G Core study.
Iptacopan is an oral drug that may be an effective treatment for idiopathic immune complex-membranoproliferative glomerulonephritis (IC-MPGN). Iptacopan is a complement factor B inhibitor that blocks the alternative complement pathway (AP). Iptacopan is a promising treatment for IC-MPGN because dysregulation of the AP is implicated in the disease's pathophysiology.
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