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  • Eli Lilly gets CDSCO...

Eli Lilly gets CDSCO Panel Nod to Import, Market Antidiabetic Drug Tirzepatide solution for injection Single dose vial

Written By : Dr. Divya Colin |Medically Reviewed By : Dr. Kamal Kant Kohli Published On 2024-02-29T18:00:22+05:30  |  Updated On 21 March 2024 9:10 PM IST
Eli Lilly gets CDSCO Panel Nod to Import, Market Antidiabetic Drug Tirzepatide solution for injection Single dose vial
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New Delhi: The drug major Eli Lilly has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to import and market the antidiabetic drug Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml and 15mg/.5 ml solution for injection (single dose vial).

However, this approval is subject to the condition that the firm should conduct a Phase IV clinical trial and be required to submit the Phase IV clinical trial protocol to CDSCO within 03 months from the date of approval.

This came after the drug maker Eli Lilly presented the proposal for import and marketing permission of Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml and 15mg/.5 ml solution for injection (Single dose vial) along with their justification for bioequivalence (BE) and clinical trial (CT) waiver before the committee.

The firm informed that a similar formulation i.e Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml, and 15mg/.5 ml injection in the prefilled pen is already approved by the CDSCO for the same indication and now the firm has proposed for formulation in a single-dose vial presentation.

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 or for chronic weight management for adult patients that are obese or overweight with at least one weight-related comorbid condition such as hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).

Tirzepatide is a peptide molecule that acts as a dual agonist at GLP-1 and GIP receptors. It enhances the insulin response, suppresses glucagon secretion, promotes satiety, and improves insulin sensitivity.

At the recent SEC meeting for Endocrinology and Metabolism held on 13th and 14th February 2023, the expert panel reviewed the proposal for import and marketing permission of Tirzepatide along with their justification for BE and CT waiver.

After detailed deliberation, the committee recommended the import and marketing permission of Tirzepatide 2.5 mg/0.5 ml, 5mg/0.5ml, 10mg/0.5 ml, 12.5 mg/0.5 ml, and 15mg/.5 ml solution for injection (single dose vial) subject to the condition that the firm should conduct Phase-IV clinical trial.

Accordingly, the expert panel suggested that the firm should submit a Phase-IV clinical trial protocol to CDSCO within 03 months from the date of approval for further review by the committee.

Furthermore, the committee opined that the firm should fulfill the requirement of chemistry, manufacturing, and controls (CMC) data along with comparative data with that of the already approved pre-filled pen.

Also Read:Glenmark Gets CDSCO Panel Nod to Study ISB 2001 in Multiple Myeloma

eli lilycdscoantidiabetic drugtirzepatideeli lilly news
Dr. Divya Colin
Dr. Divya Colin

    Doctor of Pharmacy

    Dr. Divya Colin, a Doctor of Pharmacy Graduate with extensive experience in clinical and hospital settings and confidently equipped with diagnostic and therapeutic skills. She also has spread out exposure to Oncology Departments in Mysore Medical College and Research Institute as Oncology Pharmacist. Currently she is building a career in clinical research and clinical data management. She has been a part of Medical Dialogue since January 2022.

    Dr. Kamal Kant Kohli
    Dr. Kamal Kant Kohli

    Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751

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