On Wednesday, Novo Nordisk A/S (NYSE:NVO) submitted its supplemental marketing application to the U.S. Food and Drug Administration (FDA) for a higher dose of semaglutide injection 7.2 mg for chronic weight management.
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The new, higher dose of Wegovy (semaglutide 7.2 mg) is currently under review with the European Medicines Agency, in the U.K., and several other countries.
In the EU, Novo Nordisk expects a regulatory decision in Q1 2026.
Under the Commissioner's National Priority Voucher (CNPV) expedited program, review is expected within 1–2 months following the FDA's acceptance of the filing.
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What Does The Application Include?
The application includes results from STEP UP, a 72-week phase 3 superiority trial that evaluated the efficacy and safety of once-weekly semaglutide 7.2 mg compared to placebo and semaglutide 2.4 mg in 1,407 adults with obesity (BMI ≥30 kg/m2).
Patients with diabetes were excluded.
Data
From a mean baseline body weight of 249 pounds, patients treated with semaglutide 7.2 mg in the trial achieved an average weight loss of 20.7% after 72 weeks, compared to a reduction of 17.5% with semaglutide 2.4 mg and 2.4% with placebo.
In addition, 33.2% of 7.2 mg patients achieved a weight loss of 25% or more after 72 weeks, compared to 16.7% with semaglutide 2.4 mg and 0.0% with placebo.
When assessed to include those who discontinued, people treated with semaglutide 7.2 mg achieved weight loss of 18.7% compared to a reduction of 15.6% with semaglutide 2.4 mg and 3.9% with placebo.
90.7% of participants taking semaglutide 7.2 mg achieved a body weight reduction of greater than or equal to 5%, compared to 89.9% and 36.8% for semaglutide 2.4 mg and placebo, respectively.
Also, 31.2% of those who received semaglutide 7.2 mg achieved a weight loss of 25% or more after 72 weeks, compared to 15.3% for semaglutide 2.4 mg and 0.0% for placebo.
NVO Price Action: Novo Nordisk shares were up 3.77% at $48.83 at the time of publication on Wednesday, according to Benzinga Pro data.
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