Lilly’s daily-pill GLP-1 Foundayo wins EMA backing for EU weight-loss and diabetes use

Eli Lilly’s oral GLP-1 treatment Foundayo has received a positive recommendation from the European Medicines Agency, bringing it closer to EU approval for weight management and type 2 diabetes.

The European Medicines Agency’s medicines committee has backed Eli Lilly’s oral GLP-1 drug Foundayo, clearing the way for a final decision from the European Commission on whether the treatment can be sold across the EU. According to Nordic Life Science, the recommendation covers both weight management and type 2 diabetes, and would make Foundayo one of the first oral GLP-1 options available in Europe if it wins approval.

The agency’s assessment is based on a large clinical programme. For weight loss, the recommendation draws on two studies involving more than 4,740 adults with obesity or overweight. After 72 weeks, participants taking Foundayo lost about 5% to 11% of their body weight, depending on dose, versus roughly 2% to 2.5% with placebo, according to the European Medicines Agency. The treatment was also tested in four main diabetes trials involving 3,765 adults, where it reduced HbA1c, a measure of long-term blood sugar control, by around 1.2 to 1.9 percentage points depending on dose.

In the diabetes studies, Foundayo was compared with Novo Nordisk’s oral semaglutide, which lowered HbA1c by 1.2 to 1.5 percentage points at the 7 mg and 14 mg doses, according to the EMA’s review. Lilly has said in its own release that the drug showed strong A1C and weight-loss results in pivotal trials, including a head-to-head study against oral semaglutide. The main side effects reported were nausea, vomiting and diarrhoea, most often during dose escalation.

Foundayo, orforglipron, is a small, non-peptide molecule, which means it can be taken at any time of day, with or without food. That sets it apart from peptide-based GLP-1 treatments, which typically have stricter dosing rules. The recommendation also follows the committee’s backing in May 2026 of a tablet version of Novo Nordisk’s Wegovy, which was the first oral GLP-1 approved for weight management in the EU. The Commission now has the final say on whether Lilly’s treatment receives an EU-wide marketing authorisation.

Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.