CDSCO panel Approves Novartis Protocol Amendment proposal to study inclisiran

New Delhi: The Subject Expert Committee SEC functional under the Central Drug Standard Control Organization (CDSCO) has approved the drug major Novartis's protocol amendment proposal to study KJX839 (inclisiran), the first and only small interfering RNA (siRNA) therapy to reduce low-density lipoprotein cholesterol (LDL-C) levels.

This came after the firm presented protocol amendment version 01 dated 16.08.2023 and protocol amendment version 02 dated 23.11.2023 for protocol No. CKJX839D12303.

This is a multicenter, randomized, double-blind, placebo-controlled, parallel-group phase IIIb study evaluating the effect of inclisiran on atherosclerotic plaque progression assessed by coronary computed tomography angiography (CCTA) in participants with a diagnosis of non-obstructive coronary artery disease without previous cardiovascular events (VICTORION-PLAQUE).

KJX839, also known as inclisiran is a long-acting, synthetic small interfering RNA (siRNA) directed against the proprotein convertase subtilisin-kexin type 9 (PCSK9), which is a serine protease that regulates plasma low-density lipoprotein cholesterol (LDL-C) levels. By binding to PCSK9 messenger RNA, inclisiran prevents protein translation of PCSK9, leading to decreased concentrations of PCSK9 and plasma concentrations of LDL cholesterol.

At the recent SEC meeting for cardiovascular held on July 16, 2024, the expert panel reviewed protocol amendment version 01 dated 16.08.2023 and protocol amendment version 02 dated 23.11.2023 for protocol No. CKJX839D12303 presented by the drug major Novartis.

After detailed deliberation, the committee recommended the approval of the protocol amendment as presented by the firm.

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