Both an oral formulation and a high-dose injectable version of Novo Nordisk’s Wegovy (semaglutide) are edging closer to the European market, after a committee at the European Medicines Agency (EMA) backed their respective approvals.
In a meeting on 22 May, the Committee for Medicinal Products for Human Use (CHMP) recommended extending the marketing authorisation to both versions of Wegovy. The guidance will now pass to the European Commission (EC) for a final decision, though it is expected that the pill and high-dose version will be approved.
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If the EC follows the CHMP’s recommendation, then oral Wegovy will become the first glucagon-like peptide receptor agonist (GLP-1RA) pill approved for weight management in Europe. Novo already won US Food and Drug Administration (FDA) approval in December 2025, launching the product in the following month. Total prescriptions for Q1 2026 hit 1.3 million, with that figure rising to more than two million since launch. Those numbers translate to DKr2.3bn ($360m) in quarterly revenue for the medicine. Novo’s CEO Mike Doustdar has called the US launch a “record-breaking start.”
Clinical data from the OASIS 4 Phase III clinical trial (NCT05564117) demonstrated that Novo’s pill, along with a reduced-calorie diet and exercise, achieved an average weight loss of about 17% versus about 3% with placebo. The drug also reduces cardiovascular risk factors.
As with the US, Novo will have a first-to-market advantage in Europe. Eli Lilly’s rival pill Foundayo (orforglipron), which gained US approval in April 2025, is not yet marketed in Europe. The drugmaker is expected to launch Foundayo in Europe in 2027.
With current GLP-1RAs like subcutaneous Wegovy being injected, it is forecast that the availability of an oral formulation could lead to improved adherence, as well as make the drug available for a larger patient population.
The other regulatory win bestowed upon Novo by the CHMP was for a high-dose pen of Wegovy. Although 7.2mg Wegovy is already approved in Europe, this is given as three separate injections of 2.4mg. The single-dose pen of 7.2mg, which is already marketed in the US and UK, will provide an easier dosing option for patients.
In a statement, Doustdar said: “With Wegovy 7.2mg now recommended for approval in the single-dose pen, people with obesity can reach their weight and health goals through a convenient, easy-to-use pen.”
