Eli Lilly's Weight-Loss Pill Foundayo Wins EU Drug Regulator's Backing

3-line summary

• Eli Lilly's oral weight-loss pill Foundayo (orforglipron) received a recommendation for approval from an EMA committee, for use in adult weight management and type 2 diabetes treatment; final marketing authorization rests with the European Commission. It becomes the second oral weight-loss drug to win EU backing, after Novo Nordisk's oral Wegovy.
• Bernstein analyst Courtney Breen expects a European launch for the obesity indication around year-end, while the diabetes indication's timing may vary by country based on individual reimbursement decisions. Foundayo launched in the US in April and the UK in August, posting $98 million in Q2 sales; oral Wegovy, which won EU approval in July and is also sold in the US, UK, and UAE, posted DKK 322 million (about $48.45 million) in the same period.
• Context: Foundayo's US rollout has been slower than Wegovy's, which entered the market first, though Foundayo can be taken at any time of day without food or water restrictions — a differentiator whose effect on adoption remains unclear. Lilly has filed for approval in more than 40 countries; Lilly and Novo are both competing to expand access to oral obesity drugs, in a market expected to exceed $100 billion by 2030, with oral drugs seen as potentially broadening the obesity-treatment market by attracting patients who are averse to injections.

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