Daewoong Submitted NDA for Enavogliflozin to Indonesia

Ilustrasi diabetes.
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  • Pexels/Mikhail Nilov

VIVA English – Diabetes care has the highest growth rate among chronic diseases and is expected to continue growing in the future, including Indonesia.

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The demand for new therapies is high because the number of patients continues to increase due to obesity and aging. Diabetes is divided into type 1 and type 2, and type 2 diabetes accounts for about 90% of all patients.

The global market for type 2 diabetes care is expected to grow from USD 76.7 billion in 2021 to USD 81.4 billion in 2027. Among the treatments for type 2 diabetes, SGLT2 inhibitors are increasingly being used due to their broad impact on heart or kidney disease.

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A Korean pharmaceutical company, Daewoong Pharmaceutical, has successfully developed and obtained a product license from the Korean Ministry of Food and Drug Safety for "Enavogliflozin," the first new diabetes drug in Korea affiliated with SGLT2 inhibitors.

Gedung Daewoong

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  • Daewoong Pharmaceutical
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This drug will be released in the first half of this year in Korea, and Daewoong Pharmaceutical is currently conducting clinical trials of Enavogliflozin in China and Japan.

Daewoong Pharmaceutical plans to make Enavogliflozin a global blockbuster by submitting release license applications in 10 countries every year until reaching 50 countries by 2030. Last March, Daewoong Pharmaceutical also submitted a new drug application (NDA) for Enavogliflozin to Indonesia.

Enavogliflozin has a mechanism for lowering blood sugar by selectively suppressing the SGLT2 transporter involved in glucose reabsorption in the proximal renal tubule and excreting glucose into urine.

Clinical trials have shown superior improvements and safety in blood glucose and glycated hemoglobin (HbA1C) compared to existing commercial drugs.

Enavogliflozin showed that the proportion of patients achieving diabetes control targets was more than 20% higher than conventional SGLT2 inhibitors, as they achieved less than 7% of glycated hemoglobin levels.

In addition, the drug improved weight gain, blood pressure, lipid profile, and insulin resistance. It also showed a very low incidence of infection-related side effects compared to other drugs in the same class.

“There is still high unmet demand and limited treatment options for diabetes, given the fact that the number of diabetes patients is increasing worldwide. Therefore, we will continue our research and development efforts to provide the best first-class diabetes drugs for patients,” said Daewoong Pharmaceutical CEO, Chang-jae Lee.

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