The European Medicines Agency’s committee on Friday recommended approving Eli Lilly’s weight-loss pill Foundayo. It is the second oral obesity drug to receive the agency’s backing, following Novo Nordisk’s Wegovy pill.
The recommendation now goes to the European Commission, which must review it before giving final approval for the drug to launch in the region. Both Novo and Lilly are competing to widen access to their oral medicines, as they seek a bigger share of a market that is expected to exceed $100 billion by 2030.
EU review and expected launch timing for Foundayo
The European Medicines Agency recommended marketing authorisation for Foundayo for weight management and for treating type 2 diabetes in adults. Bernstein analyst Courtney Breen expects Lilly to launch the drug in the EU for obesity around year-end. For diabetes, Breen said, “the launch timing depends on member-state reimbursement.”
Lilly said it will work with governments, payers and healthcare systems so that people who could benefit from the drug can access it. Ken Custer, president of Lilly Cardiometabolic Health, made the commitment.
Sales and competition with Novo’s Wegovy pill
Foundayo was launched in the US in April and in the UK in August. It generated $98 million in sales in the second quarter. Novo’s Wegovy pill brought in 3.22 billion Danish crowns, or $484.50 million, in the same period.
Foundayo has seen slower uptake in the US than Wegovy, which reached the market first. Lilly has highlighted a key advantage: unlike the Wegovy pill, Foundayo can be taken at any time of day without food or water restrictions. It remains unclear whether patients see that convenience as compelling enough to drive broader adoption.
How Foundayo works and its approval reach
The pill contains orforglipron, a small-molecule GLP-1 receptor agonist that can help reduce appetite and food intake. Lilly has sought approval for the drug in more than 40 countries.
Early US prescription data for oral weight-loss drugs has supported expectations that pills could expand the obesity market by attracting patients who have been reluctant to use injections.
