Eli Lilly's weight-loss pill wins EU drug regulator's backing

Eli Lilly's Foundayo Weight-Loss Pill Gets Key Backing from EU Drug Regulator

European Medicines Agency Recommends Approval of Foundayo

Oct 16 (Reuters) - The European Medicines Agency's committee on Friday recommended approval of Eli Lilly's weight-loss pill Foundayo, the second oral obesity drug to win the agency's backing after Novo Nordisk's Wegovy pill.

Next Steps for Foundayo in the EU

The recommendation will now be reviewed by the European Commission before it gives the final nod to launch the drug in the region.

Market Competition and Growth

Race Between Eli Lilly and Novo Nordisk

Both Novo and Lilly are racing to broaden access to their oral drugs, as they aim to secure a larger share of a market expected to surpass $100 billion by 2030.

Sales Performance

Foundayo was launched in the US in April and in the UK in August, and generated $98 million in sales in the second quarter. Novo's Wegovy pill generated 3.22 billion Danish crowns ($484.50 million) in the same quarter.

Regulatory Status and Availability

Approval Timeline

The pill won EU approval in July. It is also available in the US, the UK and the UAE.

EMA Recommendation Details

The EMA on Friday recommended a marketing authorisation for Foundayo for weight management and treatment of type 2 diabetes in adults.

Clinical Evidence and Drug Mechanism

Study Results

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

How Foundayo Works

The pill, which Lilly has sought approval for in more than 40 countries, contains orforglipron, a small-molecule GLP-1 receptor agonist that can help reduce appetite and food intake.

Market Impact and Patient Adoption

Potential to Expand Obesity Market

Early US prescription data for oral weight-loss drugs has supported expectations that pills could expand the obesity market by attracting patients who have been reluctant to use injections.

Comparison with Wegovy

Uptake and Patient Preferences

Foundayo has, however, seen a slower uptake in the US compared to Novo's Wegovy, which was first to the market.

Convenience Factors

Unlike Novo's Wegovy pill, Foundayo can be taken at any time of the day without food or water restrictions, a feature that Lilly has touted as a key advantage of the drug.

It remains unclear whether patients perceive Foundayo's convenience as compelling enough to drive broader adoption.

Additional Information

($1 = 6.6460 Danish crowns)

(Reporting by Sriparna Roy and Siddhi Mahatole in Bengaluru; Editing by Tasim Zahid, Leroy Leo and Shinjini Ganguli)