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European Regulator Endorses High-Dose Wegovy as Novo Nordisk Expands Weight-Loss Arsenal

MarketDash Editorial Team
1 day ago
European regulators gave a thumbs-up to Novo Nordisk's higher-dose Wegovy on Friday, backed by clinical data showing average weight loss of 20.7% over 72 weeks. The drugmaker is simultaneously pursuing approvals in the U.S., U.K., and other markets.

Novo Nordisk (NVO) just got some good news from Europe. On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for a higher dose of Wegovy—semaglutide 7.2 mg, compared to the currently approved 2.4 mg version.

This matters because higher doses mean more options for patients who need additional weight-loss support. The company is also seeking approval for a single-dose device that would deliver this 7.2 mg dose, which could make treatment more convenient.

But Europe isn't the only game in town. Novo Nordisk is currently pursuing regulatory approvals for semaglutide 7.2 mg in the U.S., U.K., and several other countries. In fact, the company submitted the new dose to the FDA in November 2025 with a Commissioner's National Priority Voucher, which can speed up the review process.

The Weight-Loss Numbers Tell a Strong Story

So what makes this higher dose worth pursuing? The clinical data is pretty compelling. In trials, people with obesity who don't have diabetes lost an average of 20.7% of their body weight at 72 weeks. That's substantial.

Even more striking: one in three participants treated with the higher-dose Wegovy achieved 25% or more weight loss at 72 weeks. And the safety profile remained consistent with the already-approved 2.4 mg dose, which is reassuring from a regulatory and patient perspective.

The positive opinion is grounded in results from the STEP UP and STEP UP T2D clinical programs, which provided the data regulators needed to feel confident about the higher dose.

Here's something particularly interesting about the weight loss: the majority—84%—came from fat mass rather than muscle. Tests confirmed that muscle function was preserved, which addresses a common concern about rapid weight loss. You want to lose fat, not the muscle that keeps you strong and metabolically healthy.

Beyond just the numbers on the scale, Wegovy has already demonstrated meaningful health benefits. The drug has shown significant reductions in cardiovascular events like heart attack and stroke, plus reduced pain from knee osteoarthritis—all obesity-related complications that affect quality of life.

Novo Nordisk shares were up 0.05% at $50.31 at the time of publication on Friday.

Back to News

European Regulator Endorses High-Dose Wegovy as Novo Nordisk Expands Weight-Loss Arsenal

MarketDash Editorial Team
1 day ago
European regulators gave a thumbs-up to Novo Nordisk's higher-dose Wegovy on Friday, backed by clinical data showing average weight loss of 20.7% over 72 weeks. The drugmaker is simultaneously pursuing approvals in the U.S., U.K., and other markets.

Novo Nordisk (NVO) just got some good news from Europe. On Friday, the European Medicines Agency's Committee for Medicinal Products for Human Use issued a positive opinion for a higher dose of Wegovy—semaglutide 7.2 mg, compared to the currently approved 2.4 mg version.

This matters because higher doses mean more options for patients who need additional weight-loss support. The company is also seeking approval for a single-dose device that would deliver this 7.2 mg dose, which could make treatment more convenient.

But Europe isn't the only game in town. Novo Nordisk is currently pursuing regulatory approvals for semaglutide 7.2 mg in the U.S., U.K., and several other countries. In fact, the company submitted the new dose to the FDA in November 2025 with a Commissioner's National Priority Voucher, which can speed up the review process.

The Weight-Loss Numbers Tell a Strong Story

So what makes this higher dose worth pursuing? The clinical data is pretty compelling. In trials, people with obesity who don't have diabetes lost an average of 20.7% of their body weight at 72 weeks. That's substantial.

Even more striking: one in three participants treated with the higher-dose Wegovy achieved 25% or more weight loss at 72 weeks. And the safety profile remained consistent with the already-approved 2.4 mg dose, which is reassuring from a regulatory and patient perspective.

The positive opinion is grounded in results from the STEP UP and STEP UP T2D clinical programs, which provided the data regulators needed to feel confident about the higher dose.

Here's something particularly interesting about the weight loss: the majority—84%—came from fat mass rather than muscle. Tests confirmed that muscle function was preserved, which addresses a common concern about rapid weight loss. You want to lose fat, not the muscle that keeps you strong and metabolically healthy.

Beyond just the numbers on the scale, Wegovy has already demonstrated meaningful health benefits. The drug has shown significant reductions in cardiovascular events like heart attack and stroke, plus reduced pain from knee osteoarthritis—all obesity-related complications that affect quality of life.

Novo Nordisk shares were up 0.05% at $50.31 at the time of publication on Friday.