Australia's TGA publishes assessment report for Wegovy in adolescents 12 and older

Australia's Therapeutic Goods Administration has published its Australian Public Assessment Report for Wegovy, Novo Nordisk's semaglutide injection, covering use of the medicine for weight management in adolescents ages 12 and older ^[1]. The report, dated September 2024, describes how the regulator evaluated an extension of the product's indication ^[1].

The document lists 3 January 2024 as the date of the TGA's decision and 29 February 2024 as the date Wegovy was entered on the Australian Register of Therapeutic Goods, under ARTG numbers 356286, 356285, 356288, 356270 and 356287 ^[1]. The sponsor named in the report is Novo Nordisk Pharmaceuticals Pty Ltd ^[1]. Wegovy is included in the Black Triangle Scheme, which the TGA uses to flag medicines it monitors more closely after approval ^[1]. The report does not say when the product reached Australian pharmacies.

Who the approval covers

Under the approved wording, Wegovy is an adjunct to a reduced-calorie diet and increased physical activity for weight management in adolescents 12 and older who have obesity and a body weight above 60 kg ^[1]. In this age group, the report defines obesity as a body mass index at or above the 95th percentile on the CDC's sex- and age-specific growth charts, rather than the adult thresholds of 25.0 to 29.9 for overweight, 30.0 or above for obesity and above 35.0 for severe obesity ^[1]. For a 12-year-old boy, the 95th-percentile cutoff is a BMI of 24.2; for a 12-year-old girl it is 25.2. By age 17.5, the cutoffs are 28.6 and 30.0 ^[1]. The report notes that BMI is a surrogate measure of body fat and may be interpreted differently across ethnic groups ^[1].

Dosing and stopping rules in the approved label

The maintenance dose is 2.4 mg once weekly, reached through a step-up schedule: 0.25 mg for weeks 1 to 4, 0.5 mg for weeks 5 to 8, 1 mg for weeks 9 to 12 and 1.7 mg for weeks 13 to 16 ^[1]. The injection is given under the skin of the abdomen, thigh or upper arm ^[1]. The approved wording says treatment should be re-evaluated and discontinued if an adolescent has not reduced BMI by at least 5% after 12 weeks on the 2.4 mg dose or the maximum tolerated dose ^[1].

The report assigns semaglutide pregnancy category D. It states that the drug should not be used during pregnancy, that women who could become pregnant are advised to use contraception during treatment, and that it should be stopped at least two months before a planned pregnancy because of its long half-life ^[1].

The document also summarizes the condition the medicine is meant to treat. It cites Australian Institute of Health and Welfare data estimating that in 2017–18, 2 in 3 Australian adults (67%) were overweight or obese — 36% overweight but not obese and 31% obese, about 12.5 million adults. Globally, high BMI was linked to 4.0 million deaths in 2015, or 7.1% of deaths from any cause, and to 120 million disability-adjusted life-years ^[1]. The report says more than two-thirds of deaths related to high BMI were due to cardiovascular disease ^[1].

Why it matters for patients

This is an Australian regulatory document and does not change FDA-approved labeling, availability or insurance coverage in the United States; US prescribing is not addressed in it ^[1]. What it does show is how one regulator framed adolescent use: eligibility tied to percentile-based BMI charts plus a body weight above 60 kg, and a defined checkpoint at 12 weeks, where treatment is meant to stop if BMI has not fallen at least 5% ^[1]. That threshold is specific to the adolescent indication described in the report and differs from the adult BMI cutoffs the same document lists ^[1]. The report also puts the pregnancy precautions in explicit terms, including the two-month gap before a planned pregnancy ^[1].

What happens next

The TGA describes AusPARs as static documents that reflect a submission at one point in time, and says a new one may be published if an indication changes or a major variation is evaluated ^[1]. Wegovy's Black Triangle listing means the medicine stays under additional monitoring, but the report gives no end date for that status ^[1]. No US regulatory filing or timeline appears in the document. When Wegovy first became available to Australian patients after registration has not been disclosed in the report ^[1].