S.Korea's Boryung gets gov’t OK for diabetes drug Trubuddy

South Korea’s Boryung Corp. on Tuesday said it received approval from the Ministry of Food and Drug Safety for its new compound diabetes drug Trubuddy.

This new and improved medicine combines two active ingredients: the SGLT-2 inhibitor dapagliflozin and thiazolidinedione (TZD)-class pioglitazone. Receiving product approval were 10-30- and 10-15-milligram tablets.

Boryung said Trubuddy is the first domestically approved compound drug combining the two ingredients. Dapagliflozin and pioglitazone are used to combat Type 2 diabetes, which accounts for 90% of all forms of the disease.

Both lower blood sugar and create a strong synergy effect when administered together by combining their benefits and offsetting each other's side effects.

Each ingredient lowers blood sugar through its own mechanism to further lower blood sugar levels. Among eight factors that cause Type 2 diabetes, dapagliflozin improves insulin secretion disorder in the pancreas, raises glucose reabsorption in kidneys and reduces glucose absorption in muscles.

Pioglitazone improves insulin secretion disorder in the pancreas, raises glucose production in the liver, reduces glucose absorption in muscle and cuts glucose absorption in fatty tissue. So clinical tests found that the combination of both ingredients was more effective in lowering blood sugar.

In addition, this combination can reduce the risk of death from cardiovascular disease and lower the risk of myocardial infarction, stroke, kidney disease and high blood pressure. Boryung said it expects Trubuddy to improve indicators of non-alcoholic fatty liver disease as well as boost insulin sensitivity and beta cell function.

In side effects, the company said TZD-containing drugs cause edema (fluid retention) and weight gain but those with SGLT-2 inhibitors offset both effects. Both ingredients also incur low risk of hypoglycemia and do not directly stimulate the pancreas, making them safe and effective treatments for Type 2 diabetics.

Write to Ye-Na Kim at yena@hankyung.com