Eli Lilly Gets CDSCO Panel Nod to Import, Market antidiabetic drug Tirzepatide
New Delhi: Pharmaceutical major, Eli Lilly has got the green signal from the Subject Expert Committee (SEC) functional under Central Drug Standard Control Organization (CDSCO) to import and market Tirzepatide 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg per 0.5ml solution for injection in a single-dose prefilled pen, used for the treatment of type II diabetes in adults.
However, this approval is subject to the condition that the drug should be sold by retail under the prescription of an Endocrinologist or internal medicine specialist only and 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.
This came after the firm presented the proposal for a grant of permission for the import and marketing of Tirzepatide 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg per 0.5ml solution for injection in a single-dose prefilled pen along with a global Phase-III clinical trial the report in which India is one of the participating countries.
Tirzepatide is a dual GIP and GLP-1 receptor agonist used for the treatment of type II diabetes in adults as an adjunct to diet and exercise. Tirzepatide is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
Glucagon-like peptide-1 (GLP-1) receptors (GLP-1R) are expressed throughout the body, including pancreatic beta-cells and the gastrointestinal tract. They have been implicated in the pathophysiology of type II diabetes mellitus as GLP-1R signaling is involved in glucose control by enhancing glucose-stimulated insulin secretion, delaying gastric transit, decreasing plasma glucagon levels, and reducing body weight by activating anorexigenic pathways in the brain.
Both glucose-dependent insulinotropic polypeptide (GIP) and GLP-1 are peptide hormones involved in glucose homeostasis: they promote glucose-stimulated insulin secretion from the pancreatic beta-cells.
Tirzepatide binds to GIP and GLP-1R with high affinity. In vitro, tirzepatide has a comparable GIP receptor binding affinity to native GIP and five times lower GLP-1R affinity than native GLP-1.
Tirzepatide potently activates the GLP-1R signaling pathway to stimulate glucose-dependent insulin secretion through activity at the GIP receptor (GIPR) or the GLP-1R.
At the recent SEC meeting for Endocrinology and Metabolism held on the 20th and 21st of April 2023, the expert panel reviewed the proposal presented by drug major Eli Lilly for the grant of permission for importing and marketing of the Tirzepatide 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg and 15mg per 0.5ml solution for injection in a single-dose prefilled pen along with a global Phase-III clinical trial a report in which India is one of the participating countries.
The committee noted that Tirzepatide is approved in the USA, European Union, Australia, Japan, Switzerland, Canada, UAE, Kuwait, Qatar, Saudi Arabia, and the United Kingdom.
After detailed deliberation, the committee recommended for grant of permission to import and market the drug Tirzepatide 2.5mg, 5mg, 7.5mg, 10mg, 12.5mg, and 15mg per 0.5ml solution for injection in a single dose prefilled pen subject to following conditions:
1. The drug should be sold by retail under the prescription of an Endocrinologist or internal medicine specialist only.
2. 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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