Eli Lilly Company Gets CDSCO Panel Nod To Import, Market Antidiabetic drug Tirzepatide for chronic weight management

New Delhi: The drug major Eli Lily Company India has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market antidiabetic medication Tirzepatide 2.5mg/0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5ml, 12.5mg/0.5ml, and 15mg/0.5ml solutions for injection in a single-dose prefilled pen and in a single-dose vial for chronic weight management.

However, this approval is subject to the condition that the firm conduct the Phase-IV clinical trial of the proposed drug. In addition to the above, the expert panel suggested that the firm should fulfil the requirement of CMC (Chemistry, manufacturing and controls)data.

This came after drug major Eli Lily presented the proposal for grant of permission to import and market Tirzepatide 2.5 mg/0.5 ml, 5 mg/0.5 ml, 7.5 mg/0.5 ml, 10 mg/0.5 ml, 12.5mg/0.5ml and 15mg/0.5ml solution for injection in a single dose prefilled pen and a single-dose vial (additional indication) along with justification, including India-specific clinical study reports from two global clinical studies in which India is also one of the participating countries before the committee.

The firm informed that Tirzepatide single-dose pre-filled pens are approved in the United States (country of origin), the European Union, the United Kingdom, the United Arab Emirates, Hong Kong, Kuwait, and Qatar, and Tirzepatide single-dose vials are approved in the United States (country of origin), the European Union, and Egypt for chronic weight management.

The firm has submitted two separate applications for the dosage form (single-dose pre-filled pens & single-dose vials) for proposed indication to this division via application no. SND/CT18/FF/2024/42512 and SND/CT18/FF/2024/42517.

Tirzepatide is in a class of medications called glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonists. It works by increasing insulin available and decreasing glucagon (a hormone that controls the amount of glucose made by the liver) available in the body.

Tripeptide activation of GLP-1 receptors improves glucose-mediated insulin secretion and decreases the secretion of glucagon. Tirzepatide activation of GIP receptors augments insulin sensitivity and secretion and thereby helps reinforce the mechanisms regulating blood glucose levels.

At the recent SEC meeting for endocrinology and metabolism held on June 19, 2024, the expert panel reviewed the proposal for the grant of permission to import and market Tirzepatide 2.5mg/0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5ml, 12.5mg/0.5ml, and 15mg/0.5ml solutions for injection in a single-dose prefilled pen and a single-dose vial (additional indication) along with justification, including India-specific clinical study reports from two global clinical studies in which India is also one of the participating countries before the committee.

After detailed deliberation, the committee recommended the grant of permission for the import and marketing of Tirzepatide 2.5mg/0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5ml, 12.5mg/0.5ml, and 15mg/0.5ml solutions for injection in a single-dose prefilled pen and in a single-dose vial for chronic weight management, subject to the condition that the firm should conduct a Phase-IV clinical trial.

Furthermore, the expert panel stated that the firm should fulfil the requirement of CMC data.

Accordingly, the committee suggested that the firm submit the Phase IV clinical trial protocol to CDSCO within 3 months from the date of approval of the drug for further review by the committee.

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