The European Medicines Agency's committee has recommended approval of Eli Lilly's (LLY) weight-loss pill Foundayo, the second oral obesity drug to win the agency's backing after Novo Nordisk's (NVO) Wegovy pill. The European Commission will now review the recommendation before giving a final decision on whether the drug can launch in the region.
Both companies are racing to broaden access to their oral treatments as they compete for a larger share of a market expected to exceed $100bn by 2030.
Foundayo launched in the US in April and in the UK in August, generating $98mn in sales in the second quarter. Novo's Wegovy pill took in 3.22bn Danish crowns ($484.50mn) over the same period. It won EU approval in July and is also available in the US, the UK and the United Arab Emirates.
The EMA recommended a marketing authorization for Foundayo for weight management and the treatment of type 2 diabetes in adults. Courtney Breen, a Bernstein analyst, expects Lilly to launch the drug in the EU for obesity around the end of the year. For diabetes, she said, "the launch timing depends on member-state reimbursement."
Ken Custer, president of Lilly Cardiometabolic Health, said the company would work with governments, payers and healthcare systems to help ensure people who could benefit from Foundayo have access to it.
The pill, for which Lilly has sought approval in more than 40 countries, contains orforglipron, a small-molecule GLP-1 receptor agonist that can help reduce appetite and food intake. Early US prescription data for oral weight-loss drugs has supported expectations that pills could expand the obesity market by attracting patients reluctant to use injections.
Foundayo has, however, seen slower uptake in the US than Wegovy, which reached the market first. Unlike the Wegovy pill, Foundayo can be taken at any time of day without food or water restrictions, a feature Lilly has promoted as a key advantage. It remains unclear whether patients will find that convenience compelling enough to drive broader adoption.