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.
IC-MPGN is a rare, fast-progressing kidney disease that can be idiopathic or secondary to other conditions. It's characterized by glomerular deposits of immune complexes containing both Ig and complement proteins.
Dysregulation of the alternative complement pathway is implicated in the pathophysiology of IC-MPGN; and currently, there are no approved targeted treatments. Iptacopan is an oral, highly potent proximal complement inhibitor that specifically binds to factor B and inhibits the alternative pathway (AP).
At the recent SEC meeting for renal drugs, the expert panel reviewed phase IIIb clinical study protocol no. CLNP023B12001B, version 03 dated 25 July 2022.
After detailed deliberation, the committee recommended the grant of permission to conduct the extension part of the study as presented by the firm.
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