CDSCO Panel Rejects Theon Pharma's Proposal for Empagliflozin, Linagliptin, Metformin FDC

New Delhi: Raising doubts over the rationality of the fixed-dose combination (FDC) in the proposed strength and its significant benefits, the Subject Expert Committee (SEC) functioning under the Central Drugs Standard Control Organization (CDSCO) has declined to accept Theon Pharmaceuticals' proposal for the FDC of Empagliflozin (10 mg/25 mg), Linagliptin (5 mg/5 mg), and Metformin Hydrochloride IP (ER) (500 mg/500 mg) film-coated bilayer tablets.

This came after the firm presented the justification and rationale for the proposed strength of the FDC before the committee in light of the earlier SEC recommendation dated 22.05.2025.

At the earlier SEC meeting, the committee observed that the firm had not provided sufficient justification for the rationality of the FDC in the proposed strength or its significant benefits. In addition, the expert panel noted that the firm had not submitted published scientific literature in peer-reviewed journals in support of the FDC in the proposed strength. The firm also did not provide justification on the desirability and essentiality of the FDC in the proposed strength. Further, the FDC in this the proposed strength is not approved internationally.

In line with the previous recommendation, the firm again presented its justification and rationale for the proposed strength of the FDC before the committee.

Empagliflozin is an inhibitor of sodium-glucose co-transporter-2 (SGLT2), the transporter 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 therapies, for the management of type 2 diabetes mellitus.

Linagliptin is a competitive, reversible DPP-4 inhibitor. Inhibition of this enzyme slows the breakdown of GLP-1 and glucose-dependent insulinotropic polypeptide (GIP). GLP-1 and GIP stimulate the release of insulin from pancreatic beta cells while inhibiting glucagon release from alpha cells. These effects together reduce hepatic glycogen breakdown and enhance insulin release in response to glucose.

Metformin is a biguanide antihyperglycemic agent and first-line pharmacotherapy used in the management of type II diabetes. It lowers blood glucose concentrations without causing hypoglycemia and is commonly described as an "insulin sensitizer," reducing insulin resistance and significantly lowering fasting plasma insulin levels.

At the recent SEC meeting for Endocrinology and Metabolism, the expert panel reviewed the justification and rationale for the proposed strength of the FDC presented by the firm.

After detailed deliberation, the committee did not find the justification satisfactory and reiterated its earlier recommendation.

Furthermore, the expert panel stated:

"In view of the above, the firm should submit the above data for further review by the committee."