CDSCO Panel Grants Novartis Protocol Amendment Proposal For anti-cholesterol drug Inclisiran
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has approved the drug major Novartis protocol amendment proposal for the clinical trial of the new anti-cholesterol drug KJX839 (Inclisiran).
This came after the drug major Novartis presented protocol amendment version 01 dated 14 July 2023 protocol No. CKJX839D12302.
CKJX839D12302 is a pivotal Phase III study designed to test the hypothesis that treatment with inclisiran sodium 300 milligrams (mg) subcutaneous (s.c.) administered on Day 1, Day 90, and every 6 months thereafter in patients at high cardiovascular (CV) risk without a prior major atherosclerotic cardiovascular disease (ASCVD) event will significantly reduce the risk of 4-Point-Major Adverse Cardiovascular Events (4P-MACE) defined as a composite of CV death, non-fatal myocardial infarction (MI), non-fatal ischemic stroke, and urgent coronary revascularization, compared to placebo.
The purpose of this study is to evaluate inclisiran sodium 300 mg s.c. (equivalent to 284 mg inclisiran) compared to placebo in reducing the risk of 4P-MACE in adult patients at high risk for their first major adverse cardiovascular event.
Inclisiran is a long-acting, synthetic small interfering RNA (siRNA) directed against proprotein convertase subtilisin-kexin type 9 (PCSK9), which is a serine protease that regulates plasma low-density lipoprotein cholesterol (LDL-C) levels.
Inclisiran acts by binding to PCSK9 messenger RNA, and prevents protein translation of PCSK9, leading to decreased concentrations of PCSK9 and plasma concentrations of LDL cholesterol. Lowering circulating plasma LDL-C levels offers an additional benefit of reducing the risk of cardiovascular disease (CVD) and improving cardiovascular outcomes, as hypercholesterolemia is a major known risk factor for CVD.
At the recent SEC meeting for Cardiovascular held on 9th January 2023, the expert panel reviewed the protocol amendment version 01 dated 14 July 2023 protocol No. CKJX839D12302.
After detailed deliberation, the committee recommended approval of the protocol amendment as presented by the firm.
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