Updated: Eli Lilly’s weight loss drug receives support from the EU medicines regulator

Analyst comments added in paragraph 7, Eli Lilly’s comments added in paragraph 8

Sriparna Roy

Reuters, October 16 - The European Medicines Agency (EMA) committee on Friday recommended approving Eli Lilly’s LLY.N weight-loss drug Foundayo, making it the second oral weight-loss pill to receive the agency’s endorsement, following Novo Nordisk’s NOVOb.CO Wegovy tablet.

The recommendation will now be reviewed by the European Commission, which will then make a final decision on whether to approve the drug in the region.

Novo Nordisk and Eli Lilly are racing to expand the reach of their oral drugs, aiming to capture a bigger share of a market expected to surpass 100 billion dollars by 2030.

Foundayo was launched in the US in April and in the UK in August (link), with second-quarter sales reaching 98 million dollars.

Novo Nordisk’s oral Wegovy generated 322 million Danish kroner (48.45 million dollars) in sales in the same quarter. The drug was approved in the EU in July (link), and is also available in the US, UK, and United Arab Emirates.

The European Medicines Agency (EMA) recommended on Friday to approve Foundayo for adult weight management and the treatment of type 2 diabetes.

Bernstein analyst Courtney Breen expects the company to launch the drug for obesity in the EU around the end of the year, adding that for the diabetes indication, “timing will depend on reimbursement policies in each member state.”

Ken Custer, president of Eli Lilly’s Cardiometabolic Health division, said that the company will work with governments, payers, and health systems to help ensure that patients who could benefit from Foundayo have access to the drug.

The oral medication has been filed for approval in more than 40 countries by Eli Lilly and contains orforglipron, a small-molecule GLP-1 receptor agonist that helps suppress appetite and reduce food intake.

Early prescription data for US oral weight-loss drugs (link) has confirmed expectations that these oral drugs could expand the obesity treatment market by attracting patients who were reluctant to use injections.

However, compared to Novo Nordisk’s first-to-market Wegovy, Foundayo’s uptake in the US market has been slower.

Unlike the Wegovy tablet, Foundayo can be taken at any time of day with no food or drink restrictions, a key advantage that Eli Lilly is promoting for the drug.

It remains unclear whether patients will find Foundayo’s convenience enough to drive wider adoption.

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(1 US dollar = 6.6460 Danish kroner)

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