Eris Lifesciences Wins CDSCO Approval for Antidiabetic FDC

Eris Lifesciences has gained approval from the Central Drugs Standard Control Organisation (CDSCO) to manufacture and market a new fixed-dose combination (FDC) of Dapagliflozin Propanediol Monohydrate, Gliclazide, and Metformin Hydrochloride. This FDC is intended for patients with type 2 diabetes mellitus and combines the benefits of all three drugs to improve blood sugar control and manage cardiovascular risks.

The approval followed the successful presentation of a bioequivalence (BE) study, which demonstrated the effectiveness of the combination. However, this approval comes with the condition that Eris Lifesciences conducts a Phase IV clinical trial. This trial will provide post-marketing data on the drug’s safety and efficacy in a broader patient population.

Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, is widely used to manage type 2 diabetes and is also indicated for patients with chronic kidney disease or heart failure, providing both renal and cardiovascular benefits. Gliclazide is a sulfonylurea that stimulates insulin release to lower blood glucose levels. Metformin, a biguanide, works by reducing glucose production in the liver and improving insulin sensitivity.

During the Subject Expert Committee (SEC) meeting on Endocrinology and Metabolism on September 19, 2024, the panel thoroughly reviewed the BE study and, after deliberation, granted approval for the FDC. As part of the regulatory process, Eris Lifesciences must submit a Phase IV clinical trial protocol to the CDSCO within three months for further evaluation by the committee. This additional study will ensure ongoing monitoring of the drug’s performance once it is available on the market.