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EU Approves Novo Nordisk's Higher-Dose Wegovy for Obesity Patients
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Key Takeaways
Novo Nordisk secured EU approval for a 7.2 mg once-weekly Wegovy dose for obesity patients.
STEP UP data showed 20.7% weight loss at 72 weeks with 7.2 mg vs 17.5% for 2.4 mg.
About 33.2% on Wegovy 7.2 mg lost at least 25% weight. Safety matched the 2.4 mg profile.
Novo Nordisk (NVO - Free Report) announced that the European Commission (EC) has approved a new 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide injection) for adults with obesity. This provides physicians with an additional treatment option for patients who require further weight reduction after being treated with the 2.4 mg dose. The decision was expected as the European Medicines Agency’s advisory committee had issued a positive opinion recommending the approval of the higher-dose Wegovy in late 2025.
Following the approval, doctors across the EU can prescribe the 7.2 mg dose as three 2.4 mg injections administered during a single weekly session. Novo Nordisk has also submitted a regulatory application seeking the approval of a dedicated 7.2 mg single-dose pen in the EU, which could become available later this year if authorized. This enables eligible adults in the EU to escalate directly from Wegovy 2.4 mg (after at least four weeks) to the 7.2 mg dose when additional weight loss is needed, while maintaining muscle function.
Wegovy injections are now offered across all 27 EU member states in strengths of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg, for use alongside a reduced-calorie diet and increased physical activity to support weight management. The 7.2 mg dose of Wegovy is already approved and marketed in the United Kingdom, and regulatory filings are under review with the FDA and other health authorities worldwide.
Please note that Wegovy is currently approved in the EU for weight management, reducing major cardiovascular events, easing HFpEF symptoms, and relieving osteoarthritis-related knee pain in patients with obesity.
In the past six months, Novo Nordisk shares have lost 9.9% against the industry‘s 27.4% growth.
Image Source: Zacks Investment Research
How Effective is NVO’s Higher-Dose Wegovy?
The EC approval is mainly supported by data from the phase III STEP UP study, which showed that obesity patients, who do not have diabetes, receiving a 7.2 mg dose of Wegovy for 72 weeks achieved an average weight loss of 20.7% compared with 2.4% with placebo and 17.5% with a 2.4 mg Wegovy dose.
Novo Nordisk also reported additional analyses from the study, showing that 33.2% of patients who took the 7.2 mg dose achieved at least 25% weight loss at 72 weeks compared with 16.7% in the 2.4 mg dose group. Data indicated that most of the weight loss with Wegovy, about 84%, was attributable to fat mass reduction, while muscle function was shown to remain intact. No patients in the placebo arm met this criterion. Per NVO, these substantial weight loss results complement the already established health benefits of Wegovy in its approved indications.
The safety and tolerability profile of the higher dose was consistent with that of the approved 2.4 mg dose. The most common side effects were usually mild to moderate in severity. The data package also included results from the phase III STEP UP T2D study, which evaluated Wegovy 7.2 mg in obesity patients with type II diabetes.
In December 2025, Novo Nordisk secured the FDA approval of the Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain weight reduction in the long term, and to reduce the risk of major adverse cardiovascular events.
The approval of oral Wegovy marked a major milestone for Novo Nordisk, making it the first GLP-1 RA approved in an oral form for weight management. Compared with injectable formulations, the pill offers a far more convenient administration option, significantly lowering treatment burden and potentially improving patient adherence. Wegovy pill was subsequently launched in the United States in early January.
Please note that a regulatory filing seeking the approval of once-daily oral semaglutide 25 mg for obesity is also currently under review in the EU.
Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share (EPS) have risen from $3.72 to $4.00. HRMY shares have surged 1.5% over the past six months.
Harmony Biosciences’ earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, with the average surprise being 7.20%.
Over the past 60 days, estimates for Alkermes’ 2026 EPS have increased from $1.54 to $1.91. ALKS shares have risen 14% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average earnings surprise being 4.58%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have risen 68.4% over the past six months.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.
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EU Approves Novo Nordisk's Higher-Dose Wegovy for Obesity Patients
Key Takeaways
Novo Nordisk (NVO - Free Report) announced that the European Commission (EC) has approved a new 7.2 mg once-weekly maintenance dose of Wegovy (semaglutide injection) for adults with obesity. This provides physicians with an additional treatment option for patients who require further weight reduction after being treated with the 2.4 mg dose. The decision was expected as the European Medicines Agency’s advisory committee had issued a positive opinion recommending the approval of the higher-dose Wegovy in late 2025.
Following the approval, doctors across the EU can prescribe the 7.2 mg dose as three 2.4 mg injections administered during a single weekly session. Novo Nordisk has also submitted a regulatory application seeking the approval of a dedicated 7.2 mg single-dose pen in the EU, which could become available later this year if authorized. This enables eligible adults in the EU to escalate directly from Wegovy 2.4 mg (after at least four weeks) to the 7.2 mg dose when additional weight loss is needed, while maintaining muscle function.
Wegovy injections are now offered across all 27 EU member states in strengths of 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg and 7.2 mg, for use alongside a reduced-calorie diet and increased physical activity to support weight management. The 7.2 mg dose of Wegovy is already approved and marketed in the United Kingdom, and regulatory filings are under review with the FDA and other health authorities worldwide.
Please note that Wegovy is currently approved in the EU for weight management, reducing major cardiovascular events, easing HFpEF symptoms, and relieving osteoarthritis-related knee pain in patients with obesity.
In the past six months, Novo Nordisk shares have lost 9.9% against the industry‘s 27.4% growth.
Image Source: Zacks Investment Research
How Effective is NVO’s Higher-Dose Wegovy?
The EC approval is mainly supported by data from the phase III STEP UP study, which showed that obesity patients, who do not have diabetes, receiving a 7.2 mg dose of Wegovy for 72 weeks achieved an average weight loss of 20.7% compared with 2.4% with placebo and 17.5% with a 2.4 mg Wegovy dose.
Novo Nordisk also reported additional analyses from the study, showing that 33.2% of patients who took the 7.2 mg dose achieved at least 25% weight loss at 72 weeks compared with 16.7% in the 2.4 mg dose group. Data indicated that most of the weight loss with Wegovy, about 84%, was attributable to fat mass reduction, while muscle function was shown to remain intact. No patients in the placebo arm met this criterion. Per NVO, these substantial weight loss results complement the already established health benefits of Wegovy in its approved indications.
The safety and tolerability profile of the higher dose was consistent with that of the approved 2.4 mg dose. The most common side effects were usually mild to moderate in severity. The data package also included results from the phase III STEP UP T2D study, which evaluated Wegovy 7.2 mg in obesity patients with type II diabetes.
In December 2025, Novo Nordisk secured the FDA approval of the Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and maintain weight reduction in the long term, and to reduce the risk of major adverse cardiovascular events.
The approval of oral Wegovy marked a major milestone for Novo Nordisk, making it the first GLP-1 RA approved in an oral form for weight management. Compared with injectable formulations, the pill offers a far more convenient administration option, significantly lowering treatment burden and potentially improving patient adherence. Wegovy pill was subsequently launched in the United States in early January.
Please note that a regulatory filing seeking the approval of once-daily oral semaglutide 25 mg for obesity is also currently under review in the EU.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
NVO’s Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #5 (Strong Sell).
Some better-ranked stocks in the biotech sector are Harmony Biosciences (HRMY - Free Report) , Alkermes (ALKS - Free Report) and Castle Biosciences (CSTL - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Harmony Biosciences’ 2026 earnings per share (EPS) have risen from $3.72 to $4.00. HRMY shares have surged 1.5% over the past six months.
Harmony Biosciences’ earnings beat estimates in two of the trailing four quarters, missing the mark on the other two occasions, with the average surprise being 7.20%.
Over the past 60 days, estimates for Alkermes’ 2026 EPS have increased from $1.54 to $1.91. ALKS shares have risen 14% over the past six months.
Alkermes’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average earnings surprise being 4.58%.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 96 cents. CSTL shares have risen 68.4% over the past six months.
Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 66.11%.