Novo Nordisk has submitted a supplemental New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a higher 7.2 mg dose of Wegovy, supported by STEP UP trial data showing greater weight loss than the current 2.4 mg dose. The filing will be reviewed under the Commissioner’s National Priority Voucher program, which shortens regulatory review to one or two months.

In the 72-week STEP UP trial, adults with obesity lost an average of 20.7% of their body weight on 7.2 mg semaglutide compared with 17.5% on 2.4 mg and 2.4% with placebo. Roughly one-third of participants on the higher dose reached 25% or more weight loss, about twice the rate of the standard dose. Earlier coverage noted that these results build on semaglutide’s established profile and reflect ongoing unmet need for people who do not reach their goals on 2.4 mg.

The accelerated review places the decision on a similar timeline to Novo’s pending 25 mg oral semaglutide submission, reflecting a broader strategy to expand dose options across injectable and oral formats. Fierce Pharma notes that Novo received the priority voucher alongside several companies selected for products tied to major national health priorities, increased affordability, or domestic manufacturing commitments.

The 7.2 mg dose is also under evaluation in Europe, with an European Medicines Agency (EMA) decision expected in early 2026. Together, these filings signal continued global momentum in obesity therapeutics and intensifying competition as manufacturers prepare for both higher-efficacy options and upcoming pricing changes.

Sources

Novo Nordisk – Press release announcing the FDA filing for the 7.2 mg dose of Wegovy.
Fierce Pharma – News article explaining the filing and the accelerated review pathway.
HCPLive – Coverage of the STEP UP trial results showing the efficacy of the 7.2 mg dose.