Wegovy HD gets FDA nod
Novo Nordisk’s new high‑dose Wegovy (HD) injection was FDA‑approved this week and delivered nearly 21% average weight loss at 72 weeks in the pivotal program — the highest mean loss yet reported for a Wegovy injection. This expands the GLP‑1 dosing options clinicians can offer for obesity and metabolic care. (prnewswire.com)
The FDA approved Wegovy HD as a 7.2 mg once‑weekly semaglutide injection on March 19, 2026, granting the decision 54 days after filing under the Commissioner's National Priority Voucher (CNPV) pilot program. (fda.gov) The agency based the approval on the STEP UP program, led by a 72‑week, phase‑3b randomized trial that enrolled 1,407 adults with obesity (BMI ≥30 kg/m2) and compared semaglutide 7.2 mg to semaglutide 2.4 mg and placebo. (thelancet.com) In the trial estimand that assumes adherence to treatment, semaglutide 7.2 mg produced a 20.7% mean body‑weight reduction at 72 weeks (18.7% under the treatment‑policy analysis), compared with 17.5% for the 2.4 mg dose, and roughly one‑third of 7.2 mg recipients lost ≥25% of body weight. (patientcareonline.com) The FDA said the safety profile was consistent with known semaglutide effects—gastrointestinal events were the most common adverse reactions—while reports of altered skin sensation occurred more frequently at the higher dose and are under further investigation. (fda.gov) Wegovy HD’s approved use is to reduce excess body weight and maintain long‑term weight reduction in adults with obesity, or adults with overweight plus at least one weight‑related condition, and the label specifies it should be used only after a patient has tolerated the 2.4 mg dose for at least four weeks. (prnewswire.com) Novo Nordisk and regulators noted the approval supplements an existing Wegovy label that already includes a 2.4 mg indication for reducing major adverse cardiovascular events based on the SELECT cardiovascular outcomes trial. (prnewswire.com)
