'36th Domestic New Drug' Birth... Daewoong Diabetes Treatment 'Enblo'

Type 2 Diabetes Patient Blood Sugar Control Medication
Active Ingredient 'Inavogliflozin'

Daewoong Pharmaceutical Headquarters Exterior (Photo by Daewoong Pharmaceutical)

[Asia Economy Reporter Chunhee Lee] The Ministry of Food and Drug Safety announced on the 30th that it has approved "Enblo Tablets 0.3 mg (active ingredient: Inavogliflozin)" developed by Daewoong Pharmaceutical for improving blood sugar control in patients with type 2 diabetes. With this, Enblo became the 36th new drug developed domestically in Korea.

Diabetes is classified into type 1 diabetes, where immune cells attack and destroy pancreatic beta (β) cells due to genetic factors, resulting in insufficient insulin production in the body, and type 2 diabetes, which is generally considered an "adult disease" caused by factors such as obesity and aging in adults over 40 years old, leading to decreased insulin secretion.

Enblo Tablets were developed as an adjunct to diet and exercise therapy essential for improving blood sugar control in patients with type 2 diabetes. The mechanism involves selectively inhibiting the sodium-glucose co-transporter (SGLT)-2, which is involved in glucose reabsorption in the kidneys, thereby blocking the reabsorption of glucose into the bloodstream and lowering blood sugar by excreting glucose through urine.

According to the global market research firm IQVIA, as of last year, the SGLT-2 inhibitor market is estimated to be about 27 trillion KRW globally, with the domestic market estimated at approximately 130 billion KRW.

In the previously released phase 3 clinical trial of Enblo, Daewoong Pharmaceutical conducted a 24-week administration on a total of 160 patients with type 2 diabetes, resulting in about a 1 percentage point reduction in glycated hemoglobin (HbA1c) in the treatment group compared to the placebo group. Statistical significance was also confirmed. Furthermore, significant improvements were observed compared to placebo in indicators such as body weight, blood pressure, low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C).

Additionally, in combination therapies with metformin dual therapy and metformin-gemigliptin triple therapy, non-inferiority was demonstrated in the rate of change in glycated hemoglobin compared to the active comparator dapagliflozin.

A Ministry of Food and Drug Safety official stated, "With this new drug approval, we expect it will help expand the range of treatment options and opportunities for patients with type 2 diabetes."