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.
The European Commission will now review the recommendation and give a final nod for the company to launch the drug in the region. Novo’s Wegovy pill won EU approval in July.
The race to broaden access to their oral drugs has become the latest battleground in Novo and Lilly’s weight-loss drug rivalry, as both aim to secure a larger share of a market expected to surpass $100 billion by 2030.
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 is available in the US, the UK and the UAE.
The EMA recommended a marketing authorisation for Foundayo for weight management and treatment of type 2 diabetes in adults.
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.
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.
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.
Unlike Novo’s Wegovy pill, Foundayo can be taken at any time of day without food or water restrictions, a feature Lilly has touted as a key advantage of the drug.
(Reporting by Sriparna Roy and Siddhi Mahatole in Bengaluru; Editing by Tasim Zahid and Leroy Leo)
