Alkem Gets CDSCO panel nod to manufacture, market antidiabetic FDC Drug

This came after the firm presented the bioequivalence (BE) and clinical trial (CT) study of the FDC Sitagliptin Phosphate plus Pioglitazone Hydrochloride plus Metformin Hydrochloride IP (as sustained released form) before the committee.

Sitagliptin is in a class of medications called dipeptidyl peptidase-4 (DPP-4) inhibitors. Sitagliptin helps to control blood sugar levels by increasing substances in the body that make the pancreas release more insulin. It also signals the liver to stop producing sugar (glucose) when there is too much sugar in the blood. This medicine does not help patients who have insulin-dependent or type 1 diabetes. Sitagliptin increases insulin production and decreases hepatic glucose overproduction. Sitagliptin prolongs the action of GLP-1 and GIP. By enhancing active incretin levels, sitagliptin increases insulin production and lowers glucagon secretion from alpha cells, which decreases hepatic glucose overproduction.

Metformin is a class of medication called biguanides. it is used to treat high blood sugar levels that are caused by a type of diabetes mellitus or sugar diabetes called type 2 diabetes. With this type of diabetes, insulin produced by the pancreas is not able to get sugar into the cells of the body where it can work properly. Metformin exerts its prevailing, glucose-lowering effect by inhibiting hepatic gluconeogenesis and opposing the action of glucagon.

Pioglitazone is in a class of medications called thiazolidinediones. Pioglitazone is used with proper diet and exercise to treat high blood sugar levels caused by type 2 diabetes. It may be used alone or with other medicines such as insulin, metformin, or sulfonylurea agents. Pioglitazone works by helping your body use insulin better. Pioglitazone improves glycaemic control in people with Type 2 diabetes by improving insulin sensitivity through its action at PPAR gamma 1 and PPAR gamma 2 and affects lipid metabolism through action at PPAR alpha.

At the recent SEC meeting for Endocrinology and Metabolism, the expert panel reviewed the BE and CT study report of the FDC Sitagliptin Phosphate plus Pioglitazone Hydrochloride plus Metformin Hydrochloride IP (as sustained released form) presented by the drug major Alkem Laboratories.

After detailed deliberation, the committee recommended the grant of permission to manufacture and market the FDC.