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Novo Nordisk Seeks FDA Approval for Higher-Dose Wegovy After Strong Trial Results

MarketDash Editorial Team
11 days ago
Novo Nordisk has filed for FDA approval of a 7.2 mg version of Wegovy after 72-week trial data showed patients lost an average of 20.7% of body weight, significantly outperforming the current 2.4 mg dose.

Novo Nordisk (NVO) is making a play for bigger weight loss numbers. On Wednesday, the pharmaceutical company submitted a supplemental marketing application to the FDA for a 7.2 mg dose of semaglutide injection, marketed as Wegovy, for chronic weight management.

This isn't just a minor tweak. The new dose is three times higher than the currently approved 2.4 mg version, and the company is betting that more drug equals more results. The higher-dose Wegovy is already under review with the European Medicines Agency, regulators in the U.K., and several other countries. In the EU, Novo Nordisk expects a regulatory decision in the first quarter of 2026.

Thanks to the Commissioner's National Priority Voucher expedited program, the FDA review timeline should be considerably faster. The agency is expected to make a decision within one to two months after accepting the filing.

What's in the Application?

The submission includes results from STEP UP, a 72-week phase 3 superiority trial that evaluated how well once-weekly semaglutide 7.2 mg performed against both placebo and the current 2.4 mg dose. The study enrolled 1,407 adults with obesity, defined as a BMI of at least 30 kg/m². Patients with diabetes were excluded from the trial.

The Weight Loss Numbers

Starting from a mean baseline body weight of 249 pounds, patients treated with semaglutide 7.2 mg achieved an average weight loss of 20.7% after 72 weeks. That compares to a reduction of 17.5% with the 2.4 mg dose and just 2.4% with placebo.

The really striking numbers come from looking at who hit the 25% weight loss threshold. Among patients taking the 7.2 mg dose, 33.2% achieved weight loss of 25% or more after 72 weeks, compared to 16.7% with the 2.4 mg dose and exactly zero percent with placebo.

When the analysis included patients who discontinued treatment, the results were still impressive. People treated with semaglutide 7.2 mg achieved weight loss of 18.7%, compared to 15.6% with the 2.4 mg dose and 3.9% with placebo.

Looking at a lower threshold, 90.7% of participants taking semaglutide 7.2 mg achieved body weight reduction of at least 5%, compared to 89.9% for the 2.4 mg dose and 36.8% for placebo.

In the intention-to-treat analysis that included discontinuations, 31.2% of those who received semaglutide 7.2 mg achieved weight loss of 25% or more after 72 weeks, compared to 15.3% for the 2.4 mg dose 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.

Back to News

Novo Nordisk Seeks FDA Approval for Higher-Dose Wegovy After Strong Trial Results

MarketDash Editorial Team
11 days ago
Novo Nordisk has filed for FDA approval of a 7.2 mg version of Wegovy after 72-week trial data showed patients lost an average of 20.7% of body weight, significantly outperforming the current 2.4 mg dose.

Novo Nordisk (NVO) is making a play for bigger weight loss numbers. On Wednesday, the pharmaceutical company submitted a supplemental marketing application to the FDA for a 7.2 mg dose of semaglutide injection, marketed as Wegovy, for chronic weight management.

This isn't just a minor tweak. The new dose is three times higher than the currently approved 2.4 mg version, and the company is betting that more drug equals more results. The higher-dose Wegovy is already under review with the European Medicines Agency, regulators in the U.K., and several other countries. In the EU, Novo Nordisk expects a regulatory decision in the first quarter of 2026.

Thanks to the Commissioner's National Priority Voucher expedited program, the FDA review timeline should be considerably faster. The agency is expected to make a decision within one to two months after accepting the filing.

What's in the Application?

The submission includes results from STEP UP, a 72-week phase 3 superiority trial that evaluated how well once-weekly semaglutide 7.2 mg performed against both placebo and the current 2.4 mg dose. The study enrolled 1,407 adults with obesity, defined as a BMI of at least 30 kg/m². Patients with diabetes were excluded from the trial.

The Weight Loss Numbers

Starting from a mean baseline body weight of 249 pounds, patients treated with semaglutide 7.2 mg achieved an average weight loss of 20.7% after 72 weeks. That compares to a reduction of 17.5% with the 2.4 mg dose and just 2.4% with placebo.

The really striking numbers come from looking at who hit the 25% weight loss threshold. Among patients taking the 7.2 mg dose, 33.2% achieved weight loss of 25% or more after 72 weeks, compared to 16.7% with the 2.4 mg dose and exactly zero percent with placebo.

When the analysis included patients who discontinued treatment, the results were still impressive. People treated with semaglutide 7.2 mg achieved weight loss of 18.7%, compared to 15.6% with the 2.4 mg dose and 3.9% with placebo.

Looking at a lower threshold, 90.7% of participants taking semaglutide 7.2 mg achieved body weight reduction of at least 5%, compared to 89.9% for the 2.4 mg dose and 36.8% for placebo.

In the intention-to-treat analysis that included discontinuations, 31.2% of those who received semaglutide 7.2 mg achieved weight loss of 25% or more after 72 weeks, compared to 15.3% for the 2.4 mg dose 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.