Wegovy HD approved by FDA as higher-dose semaglutide for weight loss

The FDA approved Wegovy HD, a 7.2 mg semaglutide injection that is triple the prior 2.4 mg dose, for weight loss and long-term weight maintenance in adults; the decision was supported by clinical data showing greater average weight reduction.

The FDA approved a new, higher-dose Wegovy (semaglutide) injection called Wegovy HD. The product delivers 7.2 mg per dose, triple the previous 2.4 mg maximum. The approval covers weight loss and long-term weight loss maintenance in adults with obesity or overweight with at least one weight-related condition. The agency granted approval to Novo Nordisk under its National Priority Voucher pilot program. Key facts: - Wegovy HD is a 7.2 mg semaglutide injection, three times the previous 2.4 mg maximum dosing. - The FDA indicated it is for reducing excess body weight and maintaining weight reduction long-term in adults with obesity or overweight with at least one weight-related condition. - Clinical data from the STEP UP trial showed average weight loss of 20.7% on the higher dose versus about 16% on the standard dose, and about one-third of higher-dose patients lost 25% or more of body weight. - Higher-dose patients with both obesity and type 2 diabetes experienced similar blood sugar lowering compared with the lower dose, according to the FDA. - The safety profile aligns with known semaglutide side effects, commonly gastrointestinal reactions; skin sensitivity, pain or burning were reported more often at the higher dose but generally resolved on their own or with dose reduction, and the FDA is investigating these adverse effects. - The FDA warned the drug should not be used by patients with a personal or family history of medullary thyroid carcinoma or by those with multiple endocrine neoplasia syndrome type 2, and the agency noted that patients should consult a doctor for guidance on proper use. Summary: The approval provides an additional higher-dose option that clinical data showed produced larger average weight loss than the standard dose. The FDA has noted and is investigating higher-dose adverse effects, including increased skin reactions. Further regulatory review of those adverse effects is underway.