Wegovy EPAR update in the EU logs liver data and new plant sites

The European Medicines Agency posted revision 20 of the public assessment file for Wegovy, Novo Nordisk's semaglutide medicine, on 26 October 2026. This Wegovy EPAR update came without a press note, and EMA did not say which step triggered it. The procedural log behind the file fills in the picture: a pending label change on liver impairment, a five year renewal signed in September, and three accepted changes to manufacturing sites in October. The tablet form, cleared by the European Commission in July, now sits on the same EU record as the weekly pen.

What the Wegovy EPAR update records

Wegovy has held an authorisation valid across the European Union since 6 January 2022, with Novo Nordisk A/S of Bagsvaerd, Denmark, as the holder. The EMA Wegovy page now lists revision 20 of that file, with no note on what changed. Revision 19, the version online before 26 October, listed the product information as last updated on 21 September 2026. The procedural log retrieved on 27 October adds steps dated in October, so the Wegovy EPAR update appears to carry those entries. The medicine summary on the page flags no new indication. It still describes weekly pens for adults and adolescents from 12 years and daily tablets for adults only, which matches what the agency recommended in May.

The most substantive item in the log is a Type II variation with a CHMP opinion dated 17 September 2026. It updates sections 4.2, 4.4, 5.1 and 5.2 of the summary of product characteristics, the label that doctors read, with data on people with hepatic impairment and on liver fibrosis from metabolic dysfunction associated steatohepatitis, known as MASH. The package leaflet changes to match. As of 27 October the log showed no Commission decision date against this variation, so the new wording is not yet confirmed as part of the binding EU terms. The other new rows are smaller in scope but matter for supply, because they record changes to where the medicine and its active ingredient are made.

Semaglutide hepatic impairment data reach the label

According to the log, the semaglutide hepatic impairment data come from a population pharmacokinetic analysis that pooled three Novo Nordisk trials, coded NN9931-4381, NN9931-4296 and NN9931-4492. This kind of analysis models how much drug reaches the blood across many patients rather than in one small test. EMA's summary says people with impaired liver function reached comparable exposures, with overlapping ranges. In trial NN9931-4492, mild hepatic impairment did not change semaglutide exposure in people with MASH. EMA's summary states that available data support the recommended dosing regimen for patients irrespective of their liver function. The update also adds text to section 5.1 on how the drug acts in the liver, though the public log does not spell out that mechanism.

EMA's summary states that available data support the recommended dosing regimen for patients irrespective of their liver function.

The scope matters for how the change should be read. The log describes text on dosing, warnings, pharmacology and drug levels in people with liver problems. It does not describe a new indication for MASH in the EU, and it reports no results on liver scarring. So the edit clarifies who can take the existing product at its usual regimen rather than adding a new use. A footnote in the log says a Commission decision follows within two months of the opinion for some variation types and within one year for others. Until a decision appears against this entry, the edit remains a committee opinion, and the authorised product information may still carry the earlier text for now.

Wegovy tablets EU authorisation and the trial behind it

The biggest change to the file this year came earlier. The CHMP, EMA's human medicines committee, backed the tablet extension on 21 May 2026, and the Commission issued its decision on 14 July, the log shows. That step added a new pharmaceutical form, four tablet strengths and an oral route to the existing licence, making the Wegovy tablets EU approval part of one shared authorisation. In May the agency described the tablets as the first GLP-1 receptor agonist for weight management developed for oral use. The same opinion and decision dates also cover a new strength in a single dose pen. The tablets are for adults only and are taken once a day on an empty stomach, while the pens remain open to adolescents.

The evidence for the tablet rests on one Phase 3 trial cited by EMA. In that study of 307 adults, people on Wegovy tablets lost on average 13.61% of their body weight over 64 weeks, against 2.18% on placebo. Some 76.3% of tablet users lost at least 5% of their weight, compared with 30.5% on placebo. The most common side effects affected the gut, among them nausea, diarrhoea, constipation, abdominal pain, dyspepsia and vomiting, mostly early in treatment. EMA judged the safety profile similar to that of the weekly injection. For comparison, the first injection study in the original file, with 1,961 people, reported an average loss of 15% at 68 weeks against 2% on placebo, in a different design.

Novo Nordisk plant changes and national prices to watch

The October rows concern manufacturing. Two Type IB notifications accepted on 5 and 12 October add or replace a site for manufacturing operations on the finished product, and a worksharing notification accepted on 15 October changes the site used for the active substance or an intermediate. In September the log also recorded a larger finished product batch scale through a duplicated line, and a longer shelf life. The public log names no site, country or capacity, and Novo Nordisk has not tied these filings to a specific plant in the material reviewed for this Wegovy EPAR update. What the entries do show is that the EU record of where the medicine is made keeps changing, months after the tablet joined it.

Access is the other open question. EMA said in May that once the extension was granted, price and reimbursement would be decided by each member state within its own health system. The revised file says nothing about launch timing, list prices or insurance cover for the tablets in any EU country, and none are reported here. In markets where the main semaglutide patent has lapsed, our semaglutide patent expiry map shows Novo leaning on its pill and later patents. In the EU, both forms are prescription only, according to EMA. Supplies sold outside that chain carry real risk, as the recent counterfeit pens seized in Birmingham by UK authorities showed.

Conclusion

The Wegovy EPAR update of 26 October is a records event more than a new approval. It brings a pending liver label change, a completed renewal and fresh manufacturing site notices into the public EU file, beside the tablet form cleared in July. The next markers are a Commission decision on the hepatic impairment text and national choices on whether health systems will pay for the tablets. EMA has not said when either will come.