The obesity treatment 'Epeoto Injector Injection' (active ingredient: Epeglenatide) developed by Hanmi Pharmaceutical has received domestic product approval. It is the first GLP-1-based obesity therapy developed in South Korea, and it has been listed as the 45th domestic new drug.
The Ministry of Food and Drug Safety announced on the 7th that it had approved 'Epeoto Injector Injection 2·4·6·8·10 milligrams,' developed domestically, as a new obesity treatment drug.
Epeoto Injector Injection is an injectable medication administered as an adjunct to low-calorie diet and exercise therapy for the chronic weight management of adult patients with obesity and overweight who do not have diabetes.
GLP-1 is a type of incretin hormone secreted from the intestines after meals, which plays a role in regulating blood sugar levels and suppressing appetite. Epeglenatide acts on GLP-1 receptors distributed in the central nervous system, including the hypothalamus and medulla oblongata, as well as Wi (Minister), to suppress appetite. It aids weight management by delaying gastric emptying of food to sustain satiety.
With this approval, a GLP-1-based obesity therapy independently developed by a domestic pharmaceutical company has entered the commercialization stage for the first time.
The Ministry of Food and Drug Safety conducted the approval review of Epeoto Injector Injection in accordance with the 'New Drug Product Approval and Review Procedures' guidelines established last year. A product-specific team consisting of 19 members, including specialized review personnel, was formed to review Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP), among other standards.
After the product approval application, discussions on approval and review-related matters were held with the company through customized in-person meetings and other means. The Ministry of Food and Drug Safety completed the product approval after reviewing safety and efficacy through such procedures.
A Ministry of Food and Drug Safety official stated, "Going forward, we will continue to enhance the predictability, transparency, and speed of approvals and reviews so that therapies with sufficiently confirmed safety and efficacy can be provided promptly."
in THEBIO
