CDSCO Panel Seeks Revised Phase IV Study for Zydus' Empagliflozin, Metformin FDC

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO), has asked Zydus Healthcare Limited to submit a revised, scientifically justified Phase IV clinical trial protocol for its fixed-dose combination of Empagliflozin (5 mg/10 mg/12.5 mg/25 mg) with Metformin Hydrochloride IP (ER) 1000 mg, marketed as a film-coated bilayered tablet.

This came after the firm presented the revised Phase IV clinical trial protocol before the committee, as per the condition mentioned in the permission in Form CT-23 dated 13.12.2024.

The committee stated that the indication proposed in the Phase IV clinical trial protocol should strictly be in accordance with the indication approved under Form CT-23, and that the inclusion and exclusion criteria require revision to align with the approved indication.

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.

Metformin is a biguanide antihyperglycemic used in conjunction with diet and exercise for glycemic control in type 2 diabetes mellitus. It is also used off-label for insulin resistance in polycystic ovary syndrome (PCOS).

At the recent SEC meeting, the expert panel reviewed the revised Phase IV clinical trial protocol of a fixed-dose combination of Empagliflozin (5 mg/10 mg/12.5 mg/25 mg) with Metformin Hydrochloride IP (ER) 1000 mg presented by Zydus Healthcare.

After detailed deliberation, the committee noted that

1. Indication should be as per Form CT-23.

2. Inclusion/Exclusion criteria should be revised as per the approved indication.

Accordingly, the expert panel suggested that the firm should submit a revised, scientifically justified Phase IV clinical trial study protocol for further review by the committee.