Novartis gets CDSCO Panel Nod To Import, Market Inclisiran solution for injection
New Delhi: After deliberating the interim data of a Phase-III global clinical trial of Inclisiran solution for injection presented by pharmaceutical major Novartis, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted approval to import and market Inclisiran solution for injection in prefilled syringe 284 mg/1.5 ml.
However, this nod is subject to the condition that the drug should be sold by retail under the prescription of a Cardiologist only. Furthermore, the expert panel added that the firm should submit an ongoing global clinical trial report within 3 months to CDSCO.
In addition to the above, the expert panel suggested that the firm should conduct a Phase-IV clinical trial for which the firm should submit Phase IV clinical trial protocol within 3 months of approval of the drug for review by the committee.
Inclisiran injection is used together with a proper diet, alone or together with other medicines (eg, statins), to treat heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD) in patients who need additional lowering of their LDL cholesterol.
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. By binding to PCSK9 messenger RNA, inclisiran prevents protein translation of PCSK9, leading to decreased concentrations of PCSK9 and plasma concentrations of LDL cholesterol.
The European Commission (EC) authorized the marketing of inclisiran, the first and only siRNA approved for the treatment of adults with primary hypercholesterolemia (heterozygous familial and non-familial), or mixed dyslipidemia, either alone or in combination with other lipid-lowering therapies, on December 11, 2020.
On December 22, 2021, the FDA later approved the use of inclisiran for the treatment of adults with clinical atherosclerotic cardiovascular disease or heterozygous familial hypercholesterolemia (HeFH). It is marketed under the trade name Leqvio.
At the recent SEC meeting for Cardiovascular and Renal held on 6th July 2023, the expert panel reviewed the Interim data of the Phase-III global clinical trial of Inclisiran solution for injection presented by pharmaceutical major Novartis.
The committee noted the details and also the fact that Inclisiran is already approved in 84 countries including ICH countries such as EU countries, the United States, United Kingdom, Canada, Singapore, Australia, and Switzerland and there is an unmet medical needs in the country.
After detailed deliberation, the committee recommended the grant of permission to import and market Inclisiran solution for injection in prefilled syringe 284 mg/1.5 ml for the proposed indication subject to the following conditions:
1. The firm should submit an ongoing global clinical trial report within 3 months to CDSCO.
2. The drug should be sold by retail under the prescription of a Cardiologist only.
3. The firm should conduct a Phase-IV clinical trial for which the firm should submit Phase-IV clinical trial protocol within 3 months of approval of the drug for review by the committee.
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