How did CPAC evaluate Wegovy's adolescent indication?

Needed for severely obese adolescents…additional information on suicidal ideation will be added to the approval info

The Ministry of Food and Drug Safety (MFDS)'s Central Pharmaceutical Affairs Council (CPAC) meeting report on the approval of Wegovy (semaglutide, Novo Nordisk) for a 12-and-above adolescent indication has been released, garnering attention.

 

While CPAC members generally acknowledged the need for the adolescent obesity indication for Wegovy, they agreed that stringent post-marketing safety monitoring is required.

 

The MFDS recently added Wegovy's indication for use as an adjunct to chronic weight management in adolescents aged 12 and older.

 

Wegovy can now be used for obese adolescent patients aged 12 or older with an initial Body Mass Index (BMI) corresponding to the adult threshold of 30 kg/m2 or higher, and whose body weight exceeds 60 kg.

 

The CPAC advisory report, held on July 24, was released on that day.

 

Nine of the twelve members who attended the meeting unanimously agreed on the validity of the efficacy and safety for the adolescent obesity indication.

 

One member stated, "Although there are concerns about misuse and abuse, this is a necessary drug for severely obese adolescents." Another member said, "The adverse events for the GLP agonist class will likely be similar," adding, "Obesity is a disease, and as it is expected to increase, there is a medical necessity." The consensus favored the benefits to patients outweighing concerns about misuse.

 

Another member noted, "While the adult indication includes overweight patients with comorbidities, the adolescent indication is limited to obese patients, which suggests the risk of misuse and abuse might be lower than in adults.

 

However, thorough management in clinical settings appears necessary." Consequently, the MFDS stated it would review the suggestion to include warnings about suicidal ideation in the drug's approval information.

 

In fact, warnings regarding suicidal ideation have been included in the precautions for use.

 

A clause was added to the general precautions stating: "Suicidal behavior and ideation have been reported in clinical trials of other medicines for the treatment of obesity or overweight.

 

Patients receiving this drug for chronic weight management must be monitored for the emergence or worsening of depression, suicidal ideation or behavior, and/or any abnormal changes in mood or behavior.

 

Use of this drug should be discontinued in patients who experience suicidal ideation or behavior.

 

This drug should not be used in patients with a history of suicidal behavior or active suicidal ideation." Furthermore, a plan for post-marketing surveillance (PMS) in adolescents was also approved.

 

The expansion of Wegovy's adolescent indication was primarily driven by the STEP TEENS Phase 3 clinical study.

 

Thiswas a multi-center, randomized, double-blind study involving 201 adolescents aged 12 to less than 18 who were obese or overweight with at least one weight-related comorbidity.

 

The clinical results met the primary endpoint.

 

The percentage change in BMI showed a 16.1% reduction in the Wegovy 2.4mg group (134 patients), compared to a 0.6% increase in the placebo group (67 patients).

 

The percentage of patients achieving 5% or more weight loss, a secondary confirmatory endpoint, was higher in the Wegovy 2.4 mg group (72.5%) compared to the placebo group (17.7%).

 

Additionally, the secondary exploratory endpoint of weight change (kg) showed a 15.3 kg decrease in the Wegovy 2.4 mg group, compared to a 2.4 kg increase in the placebo group.

 

The proportion of patients achieving 15% or more weight loss was also higher in the Wegovy 2.4 mg group (53.4%) than in the placebo group(4.8%).

 

Novo Nordisk Korea stated, "Wegovy is the first GLP-1-based, once-weekly obesity treatment to be approved for adolescents," stressing that it "will improve treatment access for adolescents."