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

On October 16, the European Medicines Agency (EMA) committee recommended the approval of Eli Lilly's weight-loss pill Foundayo, marking the second oral obesity drug to gain the agency's backing. Foundayo, which contains orforglipron, a small-molecule GLP-1 receptor agonist, has demonstrated the ability to aid in weight loss and treat type 2 diabetes in adults.

The recommendation for Foundayo's marketing authorization is now under review by the European Commission before the final go-ahead is granted for its launch in the region. Both Eli Lilly and Novo Nordisk are striving to expand access to their oral drugs, with the market in question expected to surpass $100 billion by 2030. Foundayo was launched in the US in April and in the UK in August, generating $98 million in sales during the second quarter.

Novo Nordisk's Wegovy pill, approved in July, generated $484.50 million in sales during the same period. The EMA endorsed Foundayo for weight management and the treatment of type 2 diabetes in adults, based on two studies involving over 4,740 adults who were obese or overweight. Patients treated with Foundayo lost between 8% and 11% of their body weight.

Unlike Novo Nordisk's Wegovy, Foundayo can be taken at any time of the day without the need for food or water restrictions, a feature that Lilly has highlighted as an advantage of the drug. However, Foundayo's uptake in the US has been slower compared to Wegovy, which was the first oral weight-loss drug to reach the market. It is uncertain whether patients find Foundayo's convenience compelling enough to drive broader adoption.