EMA committee backs the Wegovy pill and the 7.2 mg pen for Europe

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion on May 21, 2026 recommending that Wegovy (semaglutide) be approved in the European Union as an oral tablet for weight management, in four strengths: 1.5 mg, 4 mg, 9 mg and 25 mg ^[3]. The committee also backed a 7.2 mg dose of injectable Wegovy in a single pen ^[2]. If the European Commission agrees, it would be the first GLP-1 receptor agonist developed for oral use for weight management to reach the EU market ^[1].

What the committee recommended

Under the recommended wording, Wegovy tablets would be used alongside a reduced-calorie diet and increased physical activity in adults with a body mass index of 30 kg/m² or higher, or 27 to under 30 kg/m² with at least one weight-related condition such as prediabetes or type 2 diabetes, high blood pressure, abnormal cholesterol, obstructive sleep apnea or cardiovascular disease ^[3].

The tablets would be prescription-only and taken once daily on an empty stomach after at least eight hours of fasting, with a 30-minute wait before eating, drinking or taking other medicines ^[1]. One notable difference from the injection: while Wegovy injections are authorized in the EU for patients from age 12, the tablets are intended for adults only ^[1].

The trial numbers

EMA based its opinion on a phase 3 trial of 307 adults with obesity, or overweight plus at least one related condition, who took Wegovy tablets or placebo for 64 weeks along with a reduced-calorie diet and more physical activity ^[1]. Participants on the tablets lost an average of 13.61% of their body weight, compared with 2.18% on placebo, and 76.3% of the tablet group lost at least 5% of their body weight versus 30.5% on placebo ^[1].

Reuters reported a different figure for the same 64-week study period: an average 16.6% weight loss at the 25 mg dose versus 2.7% on placebo ^[2]. The sources do not explain the gap, which in obesity trials often reflects different ways of counting people who stop treatment early. The lower EMA-reported numbers are the ones tied to the regulatory opinion ^[1].

The most common side effects were gastrointestinal: nausea, diarrhea, constipation, abdominal pain, indigestion and vomiting, mostly early in treatment ^[1]. EMA said the safety profile of the daily tablets was similar to the weekly injections ^[1].

Why it matters for patients

For US readers, this is a European decision, and it does not change anything about US labeling, supply or pricing. Oral Wegovy is already sold in the United States; Novo Nordisk launched it after FDA approval, and Eli Lilly's weight-loss pill Foundayo (orforglipron) launched in April following its US approval ^[2]. Lilly's pill is still under review at EMA ^[2].

Still, the EMA review adds an independent regulator's summary of the same tablet's trial data, including the specific dosing conditions — daily, fasting, no other medicines for 30 minutes — that make an oral GLP-1 different in daily practice from a weekly shot ^[1]. Tricia Tan, professor of metabolic medicine and endocrinology at Imperial College London, told Reuters the fasting requirement is not a major barrier once patients are instructed, but that people might struggle to remember a daily pill ^[2].

The news also underscores that approval is not the same as access. Dr. Anita Phung of Lindus Health told Reuters that reimbursement policies differ across Europe and that injectable Wegovy is often limited to specialist services rather than primary care ^[2]. EMA noted that price and reimbursement decisions are made country by country ^[1].

What happens next

The CHMP opinion now goes to the European Commission for a final decision on extending the EU marketing authorization; such decisions are normally issued 67 days after the opinion is adopted ^[3]. Novo Nordisk plans to launch the pill in some markets outside the US in the second half of 2026, and the 7.2 mg pen is expected in the third quarter ^[2].

The sources do not say whether or when a 7.2 mg single-pen Wegovy option would become available in the United States, or how the European rollout might affect US supply. That is not yet known.