Novo Nordisk applies for Wegovy’s use in adolescents

MFDS plans intensive inspections of online exaggerated advertising and illegal distribution

With Novo Nordisk Korea applying for approval of Wegovy’s use in adolescents aged 12 and older, the Ministry of Food and Drug Safety is planning strengthened measures to prevent its misuse and abuse.

 

Wegovy is a glucagon-like peptide-1 (GLP-1) class obesity treatment that was launched in Korea in October last year.

 

The drug has surpassed KRW 100 billion in cumulative sales since.

 

According to industry sources on the 28th, Wegovy is currently only available for prescription to adults with a body mass index (BMI) of 30 kg/m² or higher in Korea.

 

However, the US Food and Drug Administration (FDA) has approved Wegovy for use in adolescents aged 12 and older, and the European Medicines Agency (EMA) has also approved its use in obese adolescents aged 12 and older.

 

In line with the global trend, efforts to expand the indication for adolescent use have begun in Korea as well.

 

Joon-Soo Shin, director of the MFDS’s Biopharmaceuticals and Herbal Medicines Bureau, said, “There is growing interest in the domestic obesity treatment market.

 

Not only Wegovy but also other drugs such as Mounjaro, which is scheduled to be released soon, are stirring up a craze.” Shin added, “When Wegovy was first launched, the government could not help but be concerned about its misuse or abuse.

 

While it is impossible to completely prevent such issues, we conducted intensive monitoring for one month after launch to prevent exaggerated online advertising and illegal distribution before things escalated.” As a result, 359 posts violating the Pharmacy Affairs Act by illegally facilitating sales or advertising were identified, with 57 cases (16%) involving Wegovy.

 

Shin added, “Recently, there have been requests for approval to administer Wegovy to adolescents, but unlike other countries, Korea has stricter criteria.

 

We are paying close attention to ensure that the adolescent indication also meets our standards and do not allow their indiscriminate use of obesity treatments.” Director Shin added, “Some countries have lower BMI standards than Korea and are already allowing the use of obesity drugs in adolescents.

 

If the scope of obesity drug use is expanded to include adolescents in Korea, we will need to strengthen checks for misuse, as we did when Wegovy was first released.” The MFDS also plans to continue its public awareness campaign to reduce the misuse of obesity drugs.

 

This is to prevent the indiscriminate use of obesity treatment drugs among those who are not aware of misuse and to prevent misuse and abuse of obesity treatment drugs.

 

Shin explained, “We are focusing our efforts on promoting the prevention of misuse and abuse of obesity treatment drugs rather than distributing any product-related materials.

 

We regularly distribute pamphlets and educational materials separately for professionals and patients.” Meanwhile, according to the pharmaceutical research institution IQVIA, Wegovy’s sales reached KRW 79.4 billion in the first quarter.

 

Wegovy accounted for 73.2% of sales in the overall obesity drug market.