MFDS Approves 'Epe,' First Domestically Developed GLP-1 Obesity Treatment

Hanmi Pharmaceutical's Epeoto Injector Approved

The Ministry of Food and Drug Safety (MFDS) has approved the first GLP-1 (glucagon-like peptide-1) obesity treatment developed in South Korea.

A view of Hanmi Pharmaceutical. Hanmi Science website.

On October 7, the MFDS announced that it had approved Epeo Auto-Injector 2, 4, 6, 8 and 10 mg (active ingredient: efpeglenatide), the 45th new drug developed in South Korea. This is the first time a GLP-1 obesity treatment developed in the country has been approved.

Epeo Auto-Injector is an injectable medication for chronic weight management in adults with obesity or overweight who do not have diabetes. It is administered as an adjunct to a reduced-calorie diet and exercise.

The drug acts on GLP-1 receptors distributed in the central nervous system, including the hypothalamus and medulla, and in the gastrointestinal tract. It suppresses appetite and slows gastric emptying, helping maintain a feeling of fullness. GLP-1 is an incretin hormone secreted by the gut after meals and is involved in blood glucose regulation and appetite suppression.

The MFDS reviewed the drug under the new drug approval and review procedures established last year. It formed a 19-member team dedicated to the product, including specialists in drug review, and examined Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) requirements, among other matters. After the application was submitted, the agency also supported the approval review by holding customized in-person meetings with the company.

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