Key Moments
- The European Medicines Agency’s committee recommended Eli Lilly’s Foundayo for weight management and type 2 diabetes in adults.
- Foundayo generated $98 million in second-quarter sales after launches in the US in April and the UK in August.
- Patients in studies of more than 4,740 adults lost up to 11% of their body weight on Foundayo.
Regulatory Milestone in Europe
Oct 16 (Reuters) – The European Medicines Agency’s (EMA) committee on Friday issued a positive opinion for Eli Lilly’s weight-loss pill Foundayo, positioning it as the second oral obesity therapy to receive such support after Novo Nordisk’s Wegovy pill.
The committee’s recommendation will be forwarded to the European Commission, which will review the opinion before making a final decision on whether the drug can be marketed across the region.
Competitive Landscape and Market Potential
Novo Nordisk and Eli Lilly are moving quickly to expand access to their oral obesity treatments as they compete for share in a market that is expected to exceed $100 billion by 2030.
Foundayo entered the US market in April and the UK market in August, delivering $98 million in sales in the second quarter. Over the same period, Novo’s Wegovy pill generated 3.22 billion Danish crowns ($484.50 million) in revenue.
| Drug | Company | Form | Q2 Sales | Key Markets Mentioned |
|---|---|---|---|---|
| Foundayo | Eli Lilly | Oral pill | $98 million | US, UK |
| Wegovy pill | Novo Nordisk | Oral pill | 3.22 billion Danish crowns ($484.50 million) | Not specified |
EMA Recommendation and Clinical Evidence
The EMA on Friday backed a marketing authorization for Foundayo for both weight management and treatment of type 2 diabetes in adults.
According to the agency, the weight management recommendation rests on data from two clinical studies involving more than 4,740 adults who were obese or overweight. In these trials, patients treated with Foundayo achieved body weight reductions of up to 11%.
Mechanism, Global Filings, and Existing Approvals
Foundayo contains orforglipron, described as a small-molecule GLP-1 receptor agonist designed to help reduce appetite and food intake. Eli Lilly has pursued regulatory clearance for the pill in more than 40 countries.
The pill won EU approval in July. It is also available in the US, the UK and the UAE.
Adoption Trends and Differentiation
Initial US prescription data for oral weight-loss therapies has reinforced expectations that pill-based options could widen the obesity-treatment market by engaging individuals who have hesitated to use injectable drugs.
Foundayo’s uptake in the US has lagged behind that of Novo’s Wegovy, which reached the market earlier.
A key point of differentiation is dosing flexibility: unlike Novo’s Wegovy pill, Foundayo can be taken at any time of day without specific requirements related to food or water intake, an attribute Eli Lilly has promoted as an important benefit.
However, it is not yet clear whether patients view this convenience as a sufficiently strong reason to drive a broader shift toward Foundayo.
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