EMA approves Wegovy pill and Wegovy 7.2 mg single-dose pen in the EU

Novo Nordisk said on July 15, 2026 that the European Commission granted marketing authorisation for the Wegovy pill — once-daily oral semaglutide 25 mg — for adults with obesity (BMI of at least 30) or overweight (BMI of at least 27) with at least one weight-related condition, used alongside a reduced-calorie diet and more physical activity ^[4]. It is the first GLP-1 receptor agonist in tablet form cleared for weight management across all European Union member states ^[4][2].

The Commission also approved Wegovy 7.2 mg injection in a single-dose, ready-to-use pen for people living with obesity ^[4][3]. Both decisions followed a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use in May 2026 ^[4][3].

What the trial data showed

The pill approval rests on the OASIS phase 3 program, which tested once-daily oral semaglutide at 25 mg and 50 mg in obesity across four trials enrolling roughly 1,300 adults ^[4]. The pivotal trial, OASIS 4, was a 64-week study of oral semaglutide 25 mg versus placebo in 307 adults with obesity or overweight plus one or more weight-related conditions ^[4].

In that trial, people on the pill lost about 17% of body weight, compared with about 3% on placebo, alongside lifestyle changes ^[4][2]. Roughly one in three participants taking the drug lost 20% or more ^[4][3]. Those figures are based on what Novo calls the trial product estimand — the estimated effect if everyone stayed on treatment ^[4]. Novo's second-quarter financial report describes the same OASIS 4 data as showing "up to 16.6% mean weight loss," a slightly different number from the same trial ^[1].

On tolerability, Novo said the safety profile matched injectable semaglutide, with discontinuations tied to side effects at 6.9% for the pill versus 5.9% for placebo ^[4][2]. For the 7.2 mg pen, Novo cited STEP UP data showing up to 20.7% mean weight loss ^[1]; its EU press release rounded that to 21% ^[4].

The competitive picture

The EU clearance is the fifth regulatory approval for the Wegovy pill, after the United States, the UK, the United Arab Emirates and Bahrain ^[4]. Reuters noted the decision gives Novo a head start over Eli Lilly's orforglipron, sold as Foundayo, which has not yet cleared the EU regulatory pathway ^[2].

US uptake has been steep. Novo reported that for the week ending July 17, 2026, total weekly Wegovy prescriptions in the US were around 575,000, including more than 265,000 for the pill, and that the pill has passed 5 million total prescriptions since launch ^[1]. Wegovy pill sales were DKK 3,218 million in the second quarter and DKK 5,474 million in the first half of 2026 ^[1]. Wegovy HD — the 7.2 mg injectable — launched in the US in April, and the 7.2 mg single-dose pen launched in the UK in June, with an EU rollout planned for the second half of 2026 ^[1].

Why it matters for patients

For Americans, this approval does not change what is available at US pharmacies; the pill is already sold here ^[2][4]. What it signals is scale. A company supplying an oral GLP-1 to the US, UK, UAE, Bahrain and now 27 EU countries is committing to a much larger manufacturing and distribution footprint, which is the backdrop against which US supply and pricing play out.

It also matters because labels differ by region. The EU indication for Wegovy is weight management in adults with obesity or overweight plus a weight-related condition ^[4]. In the US, Wegovy carries additional indications, including reducing the risk of major adverse cardiovascular events in adults with known heart disease and obesity or overweight, use in patients aged 12 and older, and treatment of MASH in adults with moderate to advanced liver fibrosis but not cirrhosis ^[4]. Coverage and cost in the EU will be set country by country, and these sources do not give EU prices.

Whether the single-dose 7.2 mg pen format will be offered in the US, and on what timeline, is not stated in these sources.

What happens next

Novo says it plans to launch the Wegovy pill in additional countries during the second half of 2026 ^[4][2], and to roll out the 7.2 mg single-dose pen across the EU in the same period ^[1]. No EU decision date for Lilly's Foundayo is given in these sources ^[2].