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SEC recommends granting permission to Novartis for phase III b trial of inclisiran

Gireesh Babu, New Delhi
Thursday, May 19, 2022, 08:00 Hrs  [IST]

The Subject Expert Committee (SEC) of the drug regulator has recommended granting permission to multinational pharma major Novartis for conducting additional human trials on its twice-a-year cholesterol lowering drug inclisiran, sold in other countries as Leqvio.

Novartis presented phase III b clinical trial protocol before the SEC and it was taken up for consideration in a recent Committee meeting held in the Central Drugs Standard Control Organisation (CDSCO) office in the national capital.

Analysing the risk versus benefit to the patients, it observed that the safety profile of the study drug from preclinical and clinical studies justify the conduct of the trial.

The primary objective of the study is to demonstrate the superiority of inclisiran versus placebo, administered on top of maximally tolerated statin therapy, in reducing the total coronary atheroma volume assessed by Coronary computed tomography angiography (CCTA) from baseline to month 24, conducted as per imaging acquisition guidelines and reviewed by the imaging central reader.

Inclisiran (KJX839) is a cholesterol-lowering small interfering RNA (siRNA) that inhibits the production of proprotein convertase subtilisin/kexin type 9 (PCSK9) and is a novel synthetic ribonucleic acid (RNA) small interference therapeutic, it said while observing the unmet medical need for the drug in the country.

"After detailed deliberation, the committee recommended for grant of permission to conduct the study subject to condition that more study sites from government hospitals geographically distributed in the country should be included in the study," added the SEC minutes.

Leqvio (inclisiran, KJX839), according to Novartis, is the first and only siRNA therapy to reduce low-density lipoprotein cholesterol (LDL-C) levels through an RNA interference (RNAi) mechanism of action and could help improve outcomes for patients with atherosclerotic cardiovascular disease (ASCVD), a deadly form of cardiovascular disease.

With two doses a year and effective and sustained LDL-C reduction, Leqvio works as a complement to statins. It works differently from other therapies by preventing the production of the target protein in the liver, increasing hepatic uptake of LDL-C and clearing it from the bloodstream. Leqvio is dosed initially, again at three months and then once every six months.

Novartis acquired the drug along with the acquisition of US-based biopharmaceutical firm The Medicines Company, announced in November 2019. The company, during the announcement, said that the acquisition is expected to further drive growth of the cardiovascular-renal-metabolism franchise with the potential to become one of the largest products by sales in the Novartis portfolio, leveraging Novartis’ global cardiovascular commercial capabilities.


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