European Commission approves Wegovy 7.2 mg
The EU approved a 7.2 mg maintenance dose of Wegovy (semaglutide) for adults with obesity; in the US, the higher dose is still under FDA review [1].
The European Commission has approved a higher 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide) for adults living with obesity, making it available across all 27 EU countries [1]. Novo Nordisk announced the decision on February 17, 2026, following a positive opinion from the European Medicines Agency's scientific committee, the CHMP, on December 12, 2025 [1].
The higher dose is aimed at adults who want or need more weight loss after reaching the 2.4 mg dose. Under the EU approval, doctors may move patients directly from Wegovy 2.4 mg, after at least four weeks on that dose, up to 7.2 mg [1]. For now, the 7.2 mg dose is given as three separate 2.4 mg injections taken in one sitting, still once a week [1]. Novo Nordisk says it has applied in the EU for a single-dose 7.2 mg pen, which could become available in 2026 if approved [1].
What the studies showed
The approval rests on two phase 3 trials: STEP UP, with 1,407 participants who had obesity without type 2 diabetes, and STEP UP T2D, with 512 participants who had obesity and type 2 diabetes [1]. Novo Nordisk says people in both trials taking 7.2 mg weekly, along with lifestyle changes, lost considerably more weight than those on placebo [1].
In the group without diabetes, average weight loss was about 21% among people who took the medicine as planned, compared with about 2% for placebo [1]. The trial ran roughly a year and a half [1]. About 1 in 3 participants lost 25% or more of their body weight [1]. The company reports that 84% of the weight lost on 7.2 mg came from fat mass, with tests showing preserved muscle function [1]. The press release does not break out specific weight-loss numbers for the STEP UP T2D group, so those figures are not yet known from this source.
On safety, Novo Nordisk lists the most common side effects as nausea, diarrhea, and vomiting (24.8%), plus dysesthesia — an altered or uncomfortable sensation in the skin — at a figure written as "22-9%" in the release, which appears to be a typographical rendering of 22.9% [1]. The company says these events were usually mild to moderate and went away over time [1]. The release does not report discontinuation rates or serious adverse events, so those details are not available here.
Where else the dose stands
Wegovy 7.2 mg is already approved and available in the United Kingdom, and applications are pending with the US Food and Drug Administration and regulators in several other countries [1]. The release does not give an FDA decision date.
With this approval, injectable Wegovy is available in the EU in six strengths: 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg [1]. The oral semaglutide pill version of Wegovy is available in the US and is still pending approval in the EU [1].
Why it matters for patients
For US readers, nothing changes today. The 7.2 mg dose is not approved in the United States; the FDA application is pending, and the sources give no timeline [1]. The highest approved Wegovy maintenance dose in the US remains unchanged by this European decision.
Still, the EU action signals where semaglutide dosing is heading. Until now, 2.4 mg has been the top maintenance dose for injectable Wegovy. The STEP UP results suggest a higher dose can produce more weight loss — roughly 21% on average versus about 2% on placebo — but also that gastrointestinal side effects such as nausea, diarrhea and vomiting remain common, reported in 24.8% of participants [1].
The delivery detail matters too. In the EU, patients using 7.2 mg will need three 2.4 mg injections at a time until a single-dose pen is approved [1]. That means more injections, more pens used per week, and potentially different supply and cost considerations. Whether the FDA would authorize a similar multi-injection approach in the US, or wait for a single pen, is not addressed in the company's announcement.
Cost and insurance coverage for the higher dose are not discussed in the source material, and pricing in the US would depend on FDA action that has not yet happened.
What happens next
- December 12, 2025: CHMP issued its positive opinion [1].
- February 17, 2026: European Commission granted final approval [1].
- During 2026: a 7.2 mg single-dose pen could become available in the EU if regulators approve the pending application [1].
- No date announced: FDA decision on the 7.2 mg dose in the US [1].
Sources
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