Lupin Gets CDSCO Panel Nod to Study Antidiabetic FDC

Medically Reviewed By : Dr. Kamal Kant Kohli

Published On 2024-11-01 12:30 GMT | Update On 2024-11-01 12:30 GMT

New Delhi: The drug major Lupin has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) antidiabetic drug, Empagliflozin plus Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin plus Metformin HCl IP (extended-release) (10mg+100mg+1000 mg/25mg+100mg+1000mg) film coated bilayered tablets.

However, this nod is subject to the condition that the trained physician (MD, Internal Medicine) be present during the study.

This came after drugmaker Lupin presented the proposal along with a BE study protocol before the committee. Bioequivalence (BE) studies are considered the standard for demonstrating that the performance of a generic drug product in the human body is sufficiently similar to that of its comparator product.

The fixed-dose combination of Empagliflozin plus Sitagliptin Phosphate Monohydrate IP eq. to Sitagliptin plus Metformin Hydrochloride IP (extended-release) (10 mg + 100 mg + 1000 mg and 25 mg + 100 mg + 1000mg) is indicated in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapy.

Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporters primarily responsible for the reabsorption of glucose in the kidney. It is used clinically as an adjunct to diet and exercise, often in combination with other drug therapies, for the management of type 2 diabetes mellitus.

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used in conjunction with diet and exercise to improve glycemic control in patients with type 2 diabetes mellitus. The effect of this medication leads to glucose-dependent increases in insulin and decreases in glucagon to improve control of blood sugar

Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. Metformin is considered an antihyperglycemic drug because it lowers blood glucose concentrations in type II diabetes without causing hypoglycemia. It is commonly described as an "insulin sensitizer," leading to a decrease in insulin resistance and a clinically significant reduction of plasma fasting insulin levels.

At the recent SEC meeting for endocrinology and metabolism held on October 15, 2024, the expert panel reviewed the proposal along with the BE study protocol presented by Lupin.

After detailed deliberation, the committee recommended the grant of permission to conduct the BE study with the condition that a trained physician (MD, Internal Medicine) should be present during the study.

Accordingly, the expert panel suggested that the firm should submit the BE study report along with the Phase III clinical trial protocol to CDSCO for further review by the committee.

Also Read:CDSCO Panel grants Novo Nordisk Protocol Amendment Proposal to study concizumab

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Dr. Divya Colin

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.

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Lupin Gets CDSCO Panel Nod to Study Antidiabetic FDC

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