Novo Nordisk Korea applies for anti-obesity drug to be used among children 12 and older

The South Korean office of the Danish pharmaceutical company Novo Nordisk recently requested the local authorities to permit the use of its anti-obesity medication Wegovy for children aged 12 and above.
Novo Nordisk Korea purportedly requested the permit from the Ministry of Food and Drug Safety, which currently allows the medication to be used only for those aged 18 and above. The drug was released here in October of 2024, prescribed to obese patients with a body mass index of 30 kilograms per square meter or those with a BMI of 27 who have weight-related diseases.
South Korea defines obesity as a BMI of 25 or above, different from the global standard of 30 or above.
The ministry's stance on the underage use of Wegovy is that its safety and effectiveness on children and teenagers have not been proven. Wegovy is the brand name of the diabetes and weight-loss medication sold by Novo Nordisk, also under the names Ozempic and Rybelsus.
Wegovy use in children aged at least 12 has been approved by authorities in other countries such as the European Medicines Agency and the US Food and Drug Administration, with the latter approving once-weekly injection of the medication for treatment of teens in 2022.
It was reported by the Associated Press last year that nearly 31,00 children aged 12 to 17 used the medication in 2023, with over 162,000 aged 18 to 25 using it in the same period.
A local branch of the Danish company submitted the clinical data on the adult patients when receiving the permit for domestic use, as the firm had not previously requested a permit for juvenile use. The government said in December that it will review the use for children if Novo Nordisk submits the clinical data for children.
Concerns over abuse and side effects
The drug is designed to reduce patient appetite by mimicking the actions of the hormone called GLP-1 (glucagon-like peptide-1), released after meal ingestion. It is among the class of anorectic drugs that reduce blood sugar and energy intake by activating the GLP-1 receptor.
Research indicated significant weight loss effects among the injected patients in the US. Some 45 percent of teenagers who took the medication managed to lose enough weight to drop below the clinical cutoff for obesity, according to a 2023 study conducted by researchers at the University of Minnesota and published in the International Journal of Obesity.
Possible adverse effects, including nausea, vomiting, constipation, abdominal pain, headache and fatigue, were reported. Particularly among people with type 2 diabetes, flatulence, gastroenteritis and gastroesophageal reflux disease were reported side effects.
Wegovy use has seen a significant rise in use in Korea, with public figures such as YouTuber Pani Bottle publicly saying he lost 10 kilograms with the medication. He posted on his Instagram on April 14 that his acquaintances experienced side effects such as nausea, depression and fatigue, with him personally experiencing a prolonged nausea.
With the rising popularity of Wegovy and concerns over abuse, the South Korean government in December restricted prescribing the medication via telemedicine, or remote diagnosis.
minsikyoon@heraldcorp.com