EU Medicines Agency Recommends Approval of Lilly’s Foundayo Weight-Loss Pill

BRUSSELS: (News Desk) – The European Medicines Agency’s (EMA) committee on Friday recommended approving Eli Lilly’s weight-loss pill Foundayo, making it the second oral obesity treatment to receive the agency’s backing after Novo Nordisk’s Wegovy pill.

The recommendation will now be considered by the European Commission, which will make the final decision on whether the drug can be marketed across the European Union.

Eli Lilly and Novo Nordisk are competing to expand access to oral weight-loss treatments and capture a larger share of the obesity drug market, which analysts expect could exceed $100 billion by 2030.

Foundayo entered the US market in April and launched in the UK in August. The drug generated $98 million in sales during the second quarter. Meanwhile, Novo Nordisk’s Wegovy pill recorded sales of 3.22 billion Danish kroner, equivalent to approximately $484.5 million, over the same period. The Wegovy pill received EU approval in July and is also available in the United States, the United Kingdom and the United Arab Emirates.

The EMA committee recommended granting Foundayo marketing authorisation for weight management and the treatment of type 2 diabetes in adults.

Bernstein analyst Courtney Breen expects Lilly to launch the drug in the EU for obesity around the end of the year. However, the timeline for its use in diabetes treatment will depend on reimbursement decisions made by individual member states.

Ken Custer, president of Lilly Cardiometabolic Health, said the company would work with governments, healthcare payers and health systems to help ensure that eligible patients could access the treatment.

Oral Weight-Loss Drugs Intensify Market Competition

Foundayo contains orforglipron, a small-molecule GLP-1 receptor agonist that helps reduce appetite and food intake. Lilly has sought regulatory approval for the drug in more than 40 countries as it expands its international presence.

Early prescription data from the United States has strengthened expectations that oral obesity treatments could attract additional patients, particularly those reluctant to use injectable medications.

However, Foundayo has experienced a slower uptake in the US market compared with Novo Nordisk’s Wegovy pill, which reached the market first.

One feature Lilly has highlighted as a potential competitive advantage is the convenience of taking Foundayo at any time of day without restrictions relating to food or water. Wegovy’s oral formulation, by comparison, has specific administration requirements.

It remains uncertain whether this convenience will be enough to persuade more patients to choose Foundayo and significantly accelerate its adoption.

The European Commission’s final decision will be an important step in determining the drug’s availability in the EU and its prospects in the increasingly competitive oral obesity treatment market.