Nobonodisk Pharmaceuticals Korea submits a request for approval for 'Wegovy' indication for adolescents
The prescription range of Wegovy, dubbed the 'miraculous obesity treatment,' is expected to expand to adolescents aged 12 and older.
According to the pharmaceutical industry on the 25th, Nobonodisk Pharmaceuticals Korea has applied to the Ministry of Food and Drug Safety for the indication approval of Wegovy for adolescents aged 12 and older.
Wegovy is a prescription drug that can only be prescribed to patients with a body mass index (BMI) of 30kg/㎡ or higher, or overweight patients with weight-related comorbidities such as hyperglycemia or hypertension.
Currently, Wegovy is noted in the Ministry of Food and Drug Safety's integrated drug information system as "safety and efficacy have not been established for children and adolescents under the age of 18."
As a result, the prescription of Wegovy for Korean adolescents is currently in a state of 'impossible.'
Countries abroad that have approved the prescription of Wegovy for adolescents already exist. The U.S. Food and Drug Administration (FDA) has allowed Wegovy to be used for adolescents aged 12 and older, and the European Medicines Agency (EMA) has approved its use for obese adolescents aged 12 and older.
The industry views that if Nobonodisk Pharmaceuticals Korea can prove the safety and efficacy of Wegovy for adolescents, it will likely be able to obtain the indication approval for adolescents aged 12 and older from the Ministry of Food and Drug Safety without much difficulty.
Meanwhile, the glucagon-like peptide (GLP)-1 class obesity drug 'Wegovy' is a medication that promotes insulin secretion, which is crucial for blood sugar control, thus helping to suppress appetite.
Wegovy, launched in Korea in October last year, has been reported to cause various side effects, including abdominal pain, nausea, indigestion, and lethargy, and concerns have been consistently raised regarding the risks of long-term use.
Image source: Wegovy / News1, Appearance of Wegovy / goodrx, Reference image for understanding of the article / gettyimagesbank
