Alkem gets CDSCO panel okay to manufacture, market Metformin, Sitagliptin FDC

New Delhi: The Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted permission to drug-maker Alkem for manufacturing and marketing the antidiabetic Fixed Dose Combination (FDC) drug consisting of Metformin Hydrochloride and Sitagliptin Phosphate.

This came in line with the proposal presented by the firm for the antidiabetic FDC of Metformin Hydrochloride as an extended release form and Sitagliptin Phosphate along with bioequivalence (BE) study results before the committee.

Metformin is a popular antihyperglycemic agent that belongs to the biguanide class of drugs. Currently, metformin is the drug of choice for the management of type II diabetes. It lowers blood glucose levels by decreasing hepatic glucose production (gluconeogenesis), decreasing the intestinal absorption of glucose, and increasing insulin sensitivity by increasing peripheral glucose uptake and utilization. Metformin is the drug of choice for obese type II diabetes patients.

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. Sitagliptin inhibits DPP-4, which leads to increased levels of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased levels of glucagon, and a stronger insulin response to glucose.

Earlier, at the 87th SEC meeting for Endocrinology & Metabolism held on June 15, 2021 and June 16, 2021 at CDSCO, the drug-maker Alkem  presented the BE protocol before the committee and requested manufacturing and marketing approval based on the BE study.

In response, the committee then noted that the proposal was already approved in combi-kit form and that FDC was also approved in various other strengths.

Therefore, at the earlier meeting the firm was granted permission to conduct a BE study, and in addition to this, the firm was directed that the results of the study should be presented before the committee for further consideration.

At the latest SEC meeting, the committee thoroughly examined the proposal of Alkem and the BE study results of the said combination antidiabetic drug. After detailed deliberation, the committee recommended the manufacturing and marketing of the proposed FDC.