EU panel backs Lilly’s oral GLP‑1 Foundayo

On October 16, 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for Eli Lilly’s (LLY) oral drug Foundayo, whose active substance is orforglipron. The committee recommended granting marketing authorisation for the drug in the European Union for weight management and for the treatment of type 2 diabetes in adults.

The CHMP opinion is a key regulatory milestone in the EU approval pathway. Its recommendation will be sent to the European Commission, which is responsible for issuing the final, legally binding decision on whether Foundayo can be marketed across EU member states.

In material accompanying the opinion, Foundayo is described as a once‑daily oral GLP‑1 receptor agonist. The formulation is intended as a prescription‑only tablet, offering an oral approach within a drug class that has been widely developed in injectable forms for metabolic diseases.

The agent targets both weight management and glycaemic control in adults with type 2 diabetes, positioning it within the growing group of GLP‑1 therapies aimed at obesity and diabetes care. The oral route of administration differentiates Foundayo from many existing GLP‑1 receptor agonists currently available as injections.

The EMA’s summary of evidence cited dose‑dependent efficacy for Foundayo. Across the clinical trials reviewed, adults treated with the drug experienced average weight reductions of roughly 5% to 11% at 72 weeks, depending on the dose used.

These outcomes were compared with weight changes of about 2% to 2.5% in participants receiving placebo over the same period. The regulator highlighted this differentiation in weight loss as part of the rationale supporting the positive opinion for marketing authorisation.

With the CHMP’s recommendation in place, the assessment of Foundayo now moves to the European Commission for a final regulatory decision. Reporting on the process indicates that Commission decisions typically follow roughly two months after a CHMP opinion.

If the Commission issues a positive decision, Eli Lilly (LLY) would obtain EU marketing authorisation for Foundayo, enabling the company to commercialise the once‑daily oral GLP‑1 therapy for adult weight management and type 2 diabetes across EU member states.