Updated Version 2 - Eli Lilly weight loss drug receives support from EU medicines regulator

Details were added in paragraphs 5-9, and a chart was included.

Reuters, October 16 - The committee under the European Medicines Agency (EMA) on Friday recommended approval of Eli Lilly’s LLY.N weight-loss drug Foundayo, making it the second oral weight-loss drug to receive support from the agency after Novo Nordisk’s NOVOb.CO Wegovy.

The European Commission will review the recommendation and ultimately approve the company to launch the drug in the region. Novo Nordisk’s “Wegovy” weight-loss drug was approved in the EU in July (link).

The rivalry between Novo Nordisk and Eli Lilly to expand coverage in the oral drug market has escalated, as both companies strive to increase their share in a market expected to surpass $100 billion by 2030.

Foundayo was launched in the US in April, and inthe UK in August ( (link)), with second quarter sales reaching $98 million. Novo Nordisk’s Wegovy oral drug is currently available in the US, UK, and the UAE.

The EMA recommends approval of Foundayo for adult weight management and treatment of type 2 diabetes.

The agency stated that its recommendation for Foundayo in weight management is based on two studies involving more than 4,740 obese or overweight adults. Patients treated with Foundayo lost up to 11% of their body weight.

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

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The drug has been submitted by Eli Lilly for marketing approval in more than 40 countries, its ingredient is orforglipron, which is a small-molecule GLP-1 receptor agonist that helps suppress appetite and reduce food intake.

Unlike Novo Nordisk’s Wegovy tablet, Foundayo can be taken at any time of the day without restrictions on food or drink; Eli Lilly promotes this feature as a key advantage of the drug.

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