Novo Nordisk Secures FDA Approval For Higher-Dose Wegovy

The U.S. Food and Drug Administration (FDA) on Thursday approved a higher-dose version of Novo Nordisk A/S’ (NYSE:NVO) blockbuster weight-loss drug, Wegovy, marking an expansion of its treatment portfolio for adults with obesity. • Novo Nordisk shares are experiencing downward pressure. What’s pulling NVO shares down? The approval comes via the Commissioner's National Priority Voucher (CNPV) expedited program. The newly approved Wegovy HD (semaglutide) injection 7.2 mg is for patients who have already tolerated the currently approved 2.4 mg dose and require additional weight reduction. The therapy is intended to be used alongside a reduced-calorie diet and increased physical activity. Clinical Data From STEP UP Trial Supports Approval The regulatory decision is based on results from the STEP UP clinical program, including a 72-week study evaluating the safety and efficacy of the 7.2 mg dose. The trial enrolled 1,407 adults with obesity, defined as a body mass index (BMI) of 30 kg/m² or higher, without diabetes. Participants receiving the higher dose demonstrated significant weight loss compared to both the placebo and the standard 2.4 mg Wegovy dose. Expanded Label Strengthens Wegovy's Position Jamey Millar, executive vice president of U.S. operations at Novo Nordisk, said the approval reinforces Wegovy's clinical profile. He noted that Wegovy remains the only GLP-1 therapy for obesity proven to reduce the risk of major cardiovascular events — including stroke, heart attack and cardiovascular death — in patients with established heart disease. Before this update, the highest approved Wegovy dose was 2.4 mg, which already carried both weight-loss and cardiovascular risk reduction indications. Novo Nordisk Wegovy Commercial Rollout Novo Nordisk said Wegovy HD will be available starting in April across more than 70,000 U.S. pharmacies, including major chains and telehealth platforms. Patients will also be able to access the therapy through NovoCare Pharmacy and savings programs aimed at reducing out-of-pocket costs for eligible users. Expands Access To Popular Weight-Loss Drugs On Wednesday, Hims & Hers Health, Inc. (NYSE:HIMS) said it is collaborating with Novo Nordisk to offer access to the only FDA-approved GLP-1 weight-loss pill, alongside injectable Wegovy in all dosages. It also plans to offer Ozempic injections in all available dosages at cash-pay prices starting at $149 a month. It also launched an "exclusive pre-launch waitlist" to give customers priority access to availability updates, transparent pricing, and the debut of the strategic collaboration. In January, the U.K.’s Medicines and Healthcare products Regulatory Agency (MHRA) Wegovy 7.2 mg dose. The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Wegovy 7.2 mg. In the EU, Novo Nordisk expects a regulatory decision in the first quarter of 2026. NVO Stock Price Activity: Novo Nordisk shares were down 2.05% at $36.78 at the time of publication on Thursday, according to Benzinga Pro data. Image via Shutterstock