Novo Nordisk Gains European Approval for Higher-Dose Weight-Loss Drug

EU approves Novo Nordisk's 7.2 mg Wegovy dose for obesity, boosting weight loss by 21% in trials. Approval comes amid profit warnings and rising competition in the obesity drug market.

Danish pharmaceutical giant Novo Nordisk has secured European Union authorization for a higher maintenance dose of its weight-management medication, Wegovy. The European Commission granted approval on February 17, 2026, for a 7.2 mg dose of the semaglutide injection, marking a technical advancement in obesity treatment. This regulatory milestone arrives as the company navigates a challenging commercial landscape characterized by rising competition and downward revisions to its profit outlook.

Clinical Data and Treatment Access

The new dosage is approved for adults with obesity across all 27 EU member states, providing physicians with an additional therapeutic option. It is specifically targeted at patients who do not achieve sufficient weight reduction on the standard 2.4 mg maintenance dose.

Authorization was based on positive outcomes from two pivotal clinical trials. The STEP UP study, involving 1,407 participants, and the STEP UP T2D study, with 512 participants, demonstrated that the 7.2 mg dose yielded an average weight loss of 21%. This compares to an approximate 2% reduction for those on a placebo. Notably, about one-third of subjects lost 25% or more of their body weight, with 84% of the total reduction comprising fat mass.

Currently, EU doctors must administer three simultaneous 2.4 mg injections to achieve the higher dose. Novo Nordisk has submitted a separate application for a dedicated 7.2 mg single-use pen, which could become available later in 2026.

Global Rollout and Share Buyback Initiative

The 7.2 mg dose is already approved and available in the United Kingdom. The company has pending applications with the U.S. Food and Drug Administration (FDA) and other international regulators. With this latest addition, Wegovy is now offered in six different strengths within the EU: 0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg, and the new 7.2 mg.

In parallel, Novo Nordisk continues to execute its ongoing share repurchase program. Since its initiation on February 4, 2026, the company has repurchased 1.75 million of its B shares at an average price of 305.03 Danish kroner, for a total value of 533.8 million kroner. The board has authorized a buyback framework of up to 15 billion kroner to be conducted over a twelve-month period.

Underlying Market Challenges Persist

Despite the positive regulatory development, the company's operating environment remains difficult. In early February 2026, Novo Nordisk issued guidance forecasting a 5% to 13% decline in both sales and operating profit for the full year, measured at constant exchange rates. This pressure stems from several factors, including price reductions in the U.S. market, altered Medicaid reimbursement rules in certain states, and intensifying competitive rivalry.

While the enhanced dosage may bolster Novo Nordisk's position in the lucrative obesity drug segment, analysts question whether it will be sufficient to offset these broader structural headwinds. The company's ability to leverage this product expansion to counter declining profitability is a key focus for market observers.