Novo Wins EU Nod for Wegovy Pill, Wegovy Single-Dose Pen (NVO)
Novo Nordisk said the pill lost about 17% of body weight in trials and is already approved in the United States, Britain and the UAE.
- On Wednesday, the European Commission approved the Wegovy pill for weight management, making it the first oral GLP-1 treatment cleared for use across the European Union.
- Clinical trial data from the OASIS program showed that participants taking 25 mg oral semaglutide reduced body weight by about 17%, compared to about 3% for those on placebo.
- Regarding tolerability, adverse event-related discontinuation rates were 6.9% for the pill compared with 5.9% for placebo, with Novo Nordisk noting the safety profile remains consistent with injectable versions.
- Novo Nordisk Chief Executive Mike Doustdar said the approval provides "another important treatment option to people living with obesity," noting tablets may be more acceptable than injections for some patients.
- The company plans to introduce the treatment in additional countries during the second half of 2026, positioning Novo ahead of Eli Lilly's Foundayo, which awaits EU regulatory clearance.
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25 mg oral semaglutide is taken once daily. In the studies, along with a correct lifestyle, it favored an average decrease of about 17%.
After the green light of the regulator, the European Commission approved the introduction of Wegovy in tablet format on the European market. Novo Nordisk Pharmaceuticals speaks at a "significant moment".
The European Medicines Agency, the Ema, said yes. The first weight reduction pill approved. Will it replace the injections used so far? With each injection, the first pill is...
Rome, 16 Jul. (Adnkronos Salute) - The European Commission has authorised the placing on the market of semaglutide in Novo Nordisk's 25 mg pill. "This is a historic time for the management of obesity and overweight: it is the first approved oral treatment for weight management in Europe," stresses the pharmaceutical in a note, "in adults with obesity (Bmi equal to or greater than 30 kg/m2) and in adults with overweight (Bmi equal to or greater t…
BT
Kristeligt DagbladThe European Commission approved on Wednesday that Novo Nordisk's Wegovy as a pill may also be marketed in the Union.
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