EMA committee backs Lilly's oral GLP-1 Foundayo for EU obesity and diabetes use

The European Medicines Agency's human medicines committee, the CHMP, recommended on 16 October 2026 that Eli Lilly's orforglipron, sold as Foundayo, be authorised in the EU for weight management and for type 2 diabetes in adults ¹². The opinion now goes to the European Commission, which usually decides on CHMP recommendations within a few weeks ¹.

What the committee decided

Foundayo is an oral GLP-1 receptor agonist taken as one tablet a day. EMA presents it as an alternative to injectable GLP-1 drugs and to the other oral option in the class ². The applicant is Eli Lilly Nederland B.V., and the indication covers obesity and type 2 diabetes mellitus in adults ².

The opinion came out of the committee's 12 to 15 October meeting, which produced 6 positive opinions on new medicines and 5 on extensions of indication ². EMA's running totals for 2026 now stand at 72 positive opinions on new medicines and 8 negative ones ². At the same meeting the committee backed Revolution Medicines' Rasonque for pancreatic cancer and Ascendis Pharma's Yuviwel for achondroplasia in children, and it confirmed on re-examination its refusal of Omeros' Yartemlea ².

Foundayo's dosing differs from Novo Nordisk's oral semaglutide products. Patients taking Rybelsus or the Wegovy pill have to swallow them fasting after the night and then wait at least 30 minutes before eating or drinking, whereas Foundayo can be taken at any hour, with or without food or water ¹.

What it means for the market

If the Commission follows the committee, Foundayo would become the second oral GLP-1 agonist on the EU market, after the Wegovy pill that was approved in July for weight management alone ¹. In type 2 diabetes it would go up against Rybelsus, which has been sold in the EU since 2020 and earns more than $3 billion ¹.

Novo starts ahead in tablets. Oral Wegovy brought in around $850 million worldwide in the first half of 2026, against $98 million for Foundayo, all of it booked in the second quarter after a later launch ¹. Market researchers put oral drugs at roughly a third of obesity prescriptions in the US, where Novo takes more than 80% of new oral prescriptions, while Lilly leads in injectable incretins ¹. The EU opinion therefore opens a second market where the two companies will compete on tablets as well as injections ¹.

For European payers, the opinion adds a second tablet to a class whose EU sales have so far come mostly from injections, and one without the fasting rule of Novo's pills ¹. Pricing, reimbursement and launch timing country by country are not given in the sources and remain unknown.

Caveats

A CHMP opinion is a recommendation, not an authorisation, and Foundayo's EU status is listed as pending a Commission decision ². The sales comparisons are worldwide figures for a single half-year, and the share data come from the US rather than Europe ¹. The sources give no detail of the trial evidence the committee weighed.

EMA says the minutes of the October meeting will be published in the coming weeks ².