Eli Lilly and Company gets CDSCO panel nod to import, market Tirzepatide Multiple Dose Pen

This came after Eli Lilly and Company (India) presented the justification for Cmax values at a 90% confidence interval based on clinical data and intended use.

Tirzepatide is a novel dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist, used for the treatment of type II diabetes in adults as an adjunct to diet and exercise.

The exact mechanism of action of tirzepatide has not been fully elucidated; however, dual agonism at GIP and GLP-1R may contribute to the glycemic and weight control effects of the drug. Studies demonstrated that co-administration of GIP and a GLP-1R agonist significantly increased insulin response and suppressed glucagon secretion compared to separate administration of either hormone alone. Tirzepatide binds to GIP and GLP-1R with high affinity. Tirzepatide potently activates the GLP-1R signalling pathway to stimulate glucose-dependent insulin secretion through activity at the GIP receptor (GIPR) or the GLP-1R.

At the earlier SEC meeting, the firm presented their proposal for grant of permission to import and market Tirzepatide multiple dose pens (addition of new presentation, Kikpen): 2.5 mg/0.6 ml, 5.0 mg/0.6 ml, 7.5 mg/0.6 ml, 10.0 mg/0.6 ml, 12.5 mg/0.6 ml, and 15.0 mg/0.6 ml, along with a bioequivalence study report of Tirzepatide subcutaneously by a fixed-dose multi-use prefilled pen versus a single-dose pen in healthy participants conducted in the USA and with a request for waiver of the Phase-III clinical trial before the committee.

Responding to the above, the expert panel at the earlier meeting for endocrinology and metabolism opined that the firm should submit interim efficacy data of the Phase IV clinical trial of already approved single-dose prefilled pen formulations in the Indian population along with global safety and efficacy data on multidose prefilled pen products with preservatives to CDSCO for further review by the committee.

Now, in continuation, at the recent SEC meeting for endocrinology and metabolism held on 11.12.2024, the drug major Eli Lilly and Company (India) presented the justification for Cmax values at a 90% confidence interval based on clinical data and intended use.

In addition to the above, the firm has informed that Tirzepatide Multiple Dose Pen (KwkPen) is already approved in UK, Europe, Canada, etc.

After detailed deliberation, the committee recommended the grant of permission for the import and marketing of Tirzepatide Multiple Dose Pens (additional to the new presentation—KwkPen): 2.5 mg/0.6 mL, 5 mg/0.6 mL, 7.5 mg/0.6 mL, 10.0 mg/0.6 mL, 12.5 mg/0.6 mL, and 15.0 mg/0.6 mL in India, with the condition that the firm should conduct a Phase-IV clinical trial.

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