A European Medicines Agency (EMA) panel has backed Eli Lilly’s Foundayo (orforglipron) for approval, helping the drugmaker close the gap on Novo Nordisk in the obesity pill arena.
The agency’s human medicines committee (CHMP) endorsed Foundayo for both weight loss and type 2 diabetes. As with other glucagon-like peptide-1 receptor agonists (GLP-1RAS), the therapy is intended for use alongside a healthy diet and physical activity.
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The backing means Foundayo is likely to become the second oral GLP-1RA approved in the EU after Novo Nordisk’s oral Wegovy (semaglutide). The Danish drugmaker has raced ahead in the oral GLP-1RA space, with Lilly second to market in the US, UK, and Europe. However, Novo’s pill is approved in these territories for weight management only.
Alongside facing off against oral Wegovy in obesity, Foundayo will now directly compete with Novo’s Rybelsus brand of oral semaglutide in type 2 diabetes. The pill remained a blockbuster drug in 2025 despite increased competition. Rybelsus comes in lower doses tailored for blood sugar control.
Lilly’s ATTAIN-1 (NCT05869903) and ATTAIN-2 (NCT05872620) studies, both Phase III trials, demonstrated that adults with obesity on the highest dose of the pill lost up to 11.2% of their body weight, compared to a ceiling of 2.5% in the placebo group. The ACHIEVE programme, which evaluated Foundayo in type 2 diabetes patients, reported significant improvements in blood sugar control and body weight.
Novo’s pivotal OASIS programme (NCT05035095, NCT05564117) revealed that the highest dose of its tablet led to weight loss of around 13.6%.
Given its first-mover advantage, oral Wegovy is currently leading GLP-1RA pill revenue. It generated around $850m in sales worldwide in the first half of this year, while Foundayo generated just shy of $100m, solely in Q2 following its later launches.
Foundayo’s advantage over oral semaglutide is that it does not have meal restrictions with administration. Novo’s compound, on the other hand, must be taken on an empty stomach each morning. Analysts remain unsure whether this convenience will translate to stronger adoption than oral Wegovy.
While the approval of oral GLP-1RAs are transforming the cardiometabolic arena, injectables still retain a dominant position. In Q2, Lilly’s performance was fuelled by tirzepatide brands Mounjaro and Zepbound, with the type 2 diabetes and obesity drugs accounting for around 64% of revenue. Mounjaro sales spiked 91% to hit $9.9bn, while Zepbound grew 44% to $4.9bn. This far out-performed Novo’s injectable semaglutide franchise, which brought in $7.8bn globally.
Indeed, analysis by GlobalData says that tirzepatide holds the potential to outperform oral and injectable semaglutide in type 2 diabetes patients. Real-world data presented at the European Association for the Study of Diabetes (EASD) Annual Meeting 2026 showcased the drug’s higher effectiveness in helping patients achieve glycaemic and weight-loss targets.
GlobalData pharma analyst Maria Alexandrovich said: “In an increasingly competitive incretin market, these data could help differentiate tirzepatide from semaglutide. Its benefits across both glycaemic control and weight loss may increase its relevance as treatment decisions increasingly consider outcomes beyond HbA1c alone.”
