Wegovy Approved for Teens; Supply May be Delayed

Even though the FDA has approved a new indication for Novo Nordisk’s diabetes medication Wegovy (semaglutide) injection — the first and only anti-obesity drug for teens — it may take a while for all Wegovy users to obtain supply.

Wegovy, approved in June 2021 for chronic weight management in adults with obesity or overweight with at least one weight-related condition (such as high blood pressure, type 2 diabetes, or high cholesterol), is now also indicated for use in patients 12 years old and older, Novo Nordisk said in a news release.

Aaron S. Kelly, Ph.D.

“The prevalence of teen obesity in the United States continues to rise, affecting teens and their families. Now, more than ever, we need new options to support teens,” Aaron S. Kelly, Ph.D., co-director of the Center for Pediatric Obesity Medicine at the University of Minnesota, said in a press release. “This FDA approval offers an additional tool to address this serious, chronic, progressive disease.”

FDA’s approval is supported by data from a phase 3a study recently published in the New England Journal of Medicine.

In the STEP TEENS clinical trial, 201 adolescents were given either Wegovy or placebo once a week for 68 weeks in addition to lifestyle intervention. The Wegovy group had a mean percentage decrease of 16% in BMI at week 68, compared with a 0.6% increase in the placebo group. In addition, 77% of patients taking Wegovy experienced a BMI reduction of greater than or equal to 5%, compared with 20% taking placebo.

Adverse reactions with Wegovy treatment in adolescents 12 years of age and older were similar to those reported in adults, but adolescents had greater incidences of gallbladder problems including gallstones, low blood pressure, rash, and itching compared to adults, Novo Nordisk said. The most frequently reported adverse reactions were nausea, vomiting, diarrhea, headache, and abdominal pain.

However, Wegovy is one of the diabetes and weight loss medications that have been in short supply. Novo Nordisk’s Ozempic (semaglutide) and Lilly’s Trulicity (dulaglutide) and Mounjaro (tirzepatide) were all listed on FDA's Drug Shortages database in December 2022.

While Ozempic and Trulicity are not approved by the FDA for weight loss, clinical trials have shown weight loss benefits in both medications, boosting demand for the diabetes medications. Mounjaro, approved earlier this year to treat type 2 diabetes, is in short supply due to increased demand, according to the FDA and Lilly.

Novo Nordisk has resumed shipping all dose strengths of Wegovyto retail pharmacies nationwide, the pharma maker said in an update on its web site. “However, pharmacies may experience normal delays given the time required to order the product from their local distribution center, and geographical variabilities,” the company noted.

The pharma maker said it is increasing production capacity in 2023 and closely monitoring prescribing trends and assessing demand.

Wegovy has an annual net price of $13,618. But a final report issued in October 2022 by the Institute for Clinical and Economic Review (ICER) indicated that Wegovy exceeds typical cost-effectiveness thresholds. ICER’s health-benefit price benchmark range is between $7,500 – $9,800 per year, requiring a discount of 44% to 57%. Independent panelists participating in an evidence appraisal committee found there was adequate evidence to demonstrate a net health benefit of Wegovy compared but that it represents a low long-term value for money.

ICER’s policy recommendations suggest payers develop prior authorization criteria and consider limits on utilization that assure appropriate patient selection and treatment.