The Korean obesity treatment drug 'Epe' has begun to attract attention as it becomes available for prescription in the country.
According to the Ministry of Food and Drug Safety, Hanmi Pharmaceutical's Epe (ingredient name: epeglanatide) received product approval on October 7 and prescriptions started on October 29 at select medical institutions.
Epe is approved for use in adults without diabetes who have an initial body mass index (BMI) of 30 or higher. For those with a BMI between 27 and 30, at least one weight-related comorbidity such as hypertension, dyslipidemia, sleep apnea, or cardiovascular disease must be present.
BMI is calculated by dividing weight (kg) by height (m) squared. For example, a person weighing 65kg would have a BMI of approximately 28.9 if they are 150cm tall, while the BMI would be about 25.4 for someone who is 160cm tall.
Thus, an adult who is 150cm tall and weighs 65kg could qualify for Epe if they do not have diabetes and have a weight-related comorbidity. In contrast, a person who is 160cm tall and weighs 65kg would not qualify, as their BMI would be below 27.
For someone who is 170cm tall, a weight of about 78kg corresponds to a BMI of 27, while a weight of approximately 86.7kg corresponds to a BMI of 30. Individuals with a BMI between 27 and 30 must also have weight-related comorbidities.
The criteria for obesity diagnosis differ from those for obesity treatment drugs. The Korean Society for the Study of Obesity classifies adults with a BMI of 25 or higher as obese, but simply having a BMI of 25 does not automatically qualify someone for Epe prescription.
Epe is approved as an adjunct for chronic weight management, to be used alongside a low-calorie diet and exercise. It is administered via subcutaneous injection once a week, starting at a dose of 2mg, which is gradually increased to a maintenance dose of 10mg by the 13th week.
Clinical trials have confirmed its weight loss efficacy. According to approval documents from the Ministry of Food and Drug Safety, a Phase 3 clinical trial involving 448 Korean adults with obesity or overweight without diabetes showed an average weight reduction of 9.02% in the Epe group after 40 weeks, compared to a 0.89% reduction in the placebo group.
However, not everyone who meets the approval criteria can receive the drug. Patients with a personal or family history of medullary thyroid carcinoma or those with multiple endocrine neoplasia type 2 are prohibited from using it. Gastrointestinal side effects such as nausea, vomiting, and diarrhea may also occur.
The actual prescription of Epe will depend on a comprehensive assessment by healthcare providers, considering BMI, comorbidities, medical history, and current medications.
* This article has been translated by AI.
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