On 12 December 2025 the European Medicines Agency’s Committee for Medicinal Products for Human Use issued a positive opinion for Novo Nordisk’s 7.2‑mg Wegovy dose, the company’s higher‑strength weight‑loss formulation. The decision follows data from the STEP UP and STEP UP T2D trials, which showed an average 20.7 % weight loss at 72 weeks in adults with obesity without diabetes and that one‑third of participants achieved 25 % or more weight loss. The trials also confirmed that the higher dose preserves muscle function and maintains the cardiovascular benefits established for the 2.4‑mg product.
The positive opinion moves the drug closer to market launch in the EU, where the 7.2‑mg dose could capture patients seeking greater weight‑loss results. Novo Nordisk’s portfolio now includes a full range of Wegovy doses, positioning the company to compete more effectively against rivals such as Eli Lilly’s tirzepatide. The higher‑dose option expands the addressable market for obesity treatment and could increase market share in a segment that is growing rapidly as obesity prevalence rises worldwide.
Ludovic Helfgott, executive vice president and head of Product & Portfolio Strategy, said the approval “means a new Wegovy® option, delivering weight loss of 20.7 %, could be available for people with obesity early in the new year, pending the European Commission’s final approval.” He added that the higher dose “offers a differentiated benefit for patients who want greater weight loss, giving them more options to improve their everyday lives and long‑term health outcomes.”
The approval is expected to strengthen Novo Nordisk’s leadership in the GLP‑1 market, where the company has historically dominated but faces growing competition from tirzepatide. The 7.2‑mg dose adds a new revenue stream and could drive incremental sales in the EU, where the company already captures a large share of the obesity treatment market. Analysts note that the approval could help offset pricing pressure and broaden the company’s product mix, improving pricing power and margin resilience.
Market reaction to the positive opinion was largely positive, with investors viewing the approval as a key milestone that expands the company’s product pipeline and reinforces its competitive position. The decision is seen as a strategic win that could translate into higher sales volumes and a stronger foothold in the rapidly expanding obesity treatment market.
The EMA’s positive opinion is a critical step toward final approval by the European Commission, expected in Q1 2026. Novo Nordisk has also submitted the 7.2‑mg dose to the FDA in November 2025, with an expedited review anticipated. The company’s broader strategy includes expanding its manufacturing capacity and investing in R&D to maintain its leadership in the GLP‑1 space.
The approval underscores Novo Nordisk’s commitment to addressing unmet needs in obesity management and positions the company to capture a larger share of the growing global market for weight‑loss therapies. The higher‑dose Wegovy is expected to drive future growth and reinforce the company’s long‑term competitive advantage.
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