Kenneth Glad
European regulators are weighing a treatment change that could affect how some adults manage long-term care. The next decision will determine whether the medicine can move further toward patient access.
The European Medicines Agency’s human medicines committee has recommended expanding Wegovy’s existing EU authorization to include a tablet version, moving Novo Nordisk one step closer to offering an oral weight-management treatment for adults.
The EMA said the recommendation covers adults with obesity, as well as adults who are overweight and have related health problems, including diabetes, cardiovascular conditions and other complications linked to excess weight.
The opinion is not the same as a final approval. The European Commission must still decide whether Wegovy’s EU marketing authorization should be extended to include the tablet.
Daily tablet as an alternative to weekly injections
Wegovy is already authorized in the EU as a weekly injection. The proposed oral version is designed to be taken once per day, creating a possible needle-free option for patients if regulators complete the approval process.
The tablet would require a prescription. The EMA said patients should take it after an overnight fast of no less than eight hours, then avoid food, drinks and other medicines for half an hour afterward.
The oral treatment is meant only for adults. Wegovy injections, by contrast, are authorized for some patients from age 12.
As with the injectable product, the tablet is intended to support broader weight-management care, including changes to diet and exercise.
A phase 3 study involving 307 adults formed the main clinical basis for the recommendation. The participants had obesity or were overweight with at least one related medical condition.
Over 64 weeks, patients received either Wegovy tablets or placebo while also following a reduced-calorie diet and increasing physical activity.
The EMA reported an average body-weight reduction of 13.61% among patients who took the tablet. Those in the placebo group lost 2.18% on average.
The study also measured how many participants lost at least 5% of their starting weight. That threshold was reached by 76.3% of people in the Wegovy tablet group and 30.5% of those receiving placebo.
Side effects were mainly digestive
The EMA said the most common side effects involved the digestive system, including nausea, diarrhea, constipation, abdominal pain, indigestion and vomiting.
Those reactions were reported mostly near the start of treatment. The regulator also said the tablet’s safety profile was similar to the weekly injection.
Danish publication MedWatch reported that the CHMP recommendation was made during the committee’s latest meeting and that the case now goes to the European Commission.
CHMP opinions are a scientific step in the EU drug approval process. They are usually followed by a European Commission decision, but patients cannot assume access until that formal step is complete and national systems make their own choices.
If the Commission approves the extension, Wegovy’s EU authorization would include the tablet. Actual launch timing, pricing and reimbursement would still depend on decisions in individual countries.
Even with EU approval, patient access would depend on prescription use, company rollout plans and reimbursement decisions across national health systems.
Denmark could be among first markets
According to Danish broadcaster TV 2, Denmark could become one of the first countries outside the United States to launch the Wegovy tablet if the EU approval is finalized.
When Novo Nordisk introduced Wegovy injections in 2022, Denmark became the first market outside the U.S. where patients could buy the treatment. TV 2 said analysts believe a similar rollout strategy could happen with the oral version because Denmark is Novo Nordisk’s home market.
TV 2 business analyst Jens Nymark said one factor could complicate pricing decisions in Denmark and Europe: U.S. President Donald Trump’s proposed “Most Favored Nation” policy.
The proposal links U.S. drug prices to prices in other countries. Since Denmark traditionally has lower medicine prices, Novo Nordisk could face pressure to reduce U.S. prices if the tablet launches cheaply in Europe.
“It would be a major disappointment for Novo Nordisk if they had to cut prices further in the U.S. simply because they make it cheaper in some European markets,” Jens Nymark said.
TV 2 reported that the EMA recommendation was viewed as critical for Novo Nordisk, which is betting heavily on oral obesity treatment as a future growth driver.
Jens Nymark told the broadcaster that a rejection from the EMA committee would have been “a major catastrophe” for the company after months of preparation.
Sources: European Medicines Agency, MedWatch, TV 2 Denmark
