Foundayo EU Approval Nears as EMA Panel Backs Lilly Obesity Pill

A second GLP-1 pill heads for Europe

Eli Lilly's once-daily obesity pill, Foundayo (orforglipron), is now close to reaching European patients. The European Medicines Agency's human medicines committee, the CHMP, met on 12–15 October and recommended a marketing authorisation for the drug in adults, both for weight management and for type 2 diabetes.16 The European Commission makes the final decision. It usually follows the committee's advice within a few weeks.1117

If the Commission signs off, Foundayo will be the second oral GLP-1 drug for obesity in the EU. The first is Novo Nordisk's Wegovy pill, which won European approval in July, but only for weight management.1114 That difference in labels is important. Because Foundayo would also be cleared for type 2 diabetes, it would compete with Novo's Rybelsus, an oral semaglutide that has sold in Europe since 2020 and earns more than $3 billion a year.11

The recommendation was not a surprise, since the drug had already been approved in the US and UK. But it gives Lilly something it has lacked in the oral market so far: a chance to compete in a major region without arriving many months behind Novo.

What regulators actually endorsed

The EMA bases its weight-management opinion on two studies with more than 4,740 adults who had obesity or overweight. After 72 weeks, patients on Foundayo lost roughly 5% to 11% of their body weight, depending on dose. Patients on placebo lost about 2% to 2.5%.1315 For diabetes, the agency looked at four studies with 3,765 participants. HbA1c, a measure of long-term blood sugar, fell by 1.2 to 1.9 percentage points. That compares with 0.8 points for dapagliflozin and 1.2 to 1.5 points for oral semaglutide.15

The headline numbers differ between regions. US coverage at the time of FDA approval said patients on the top dose lost about 12% to 12.4% of body weight over 72 weeks.35 The EMA's summary tops out around 11%.13 The two figures likely come from different ways of analysing the same trials. US reporting cited averages for people who stayed on treatment.4 Neither figure is wrong, but the more conservative European number is a better guide to what patients can realistically expect. Either way, Foundayo produces less weight loss than the injectables. Injectable drugs have shown more than 20% in trials, and Novo has reported up to 17% for its own pill at the highest dose.5 None of these drugs has been compared head to head, so the numbers are not directly comparable.3

Foundayo's main selling point is how it is taken. Novo's semaglutide pills must be swallowed on an empty stomach after an overnight fast, followed by a 30-minute wait before eating or drinking. Foundayo can be taken at any time, with or without food or water.11 This is possible because orforglipron is a small, non-peptide molecule rather than a peptide.13 Novo's response has been that its active ingredient has a much longer safety record and that its pill carries a cardiovascular-risk claim.10 The most common side effects reported to the EMA were nausea, vomiting and diarrhoea. They were most frequent while the dose was being increased.13

The FDA backstory: fast, and controversial

The FDA approved Foundayo on 1 April after a review of just 50 days, under the Commissioner's National Priority Voucher pilot program. The agency called it its fastest approval of a new molecular entity since 2002.5 It was also the first new molecular entity cleared under that program.2

The speed has drawn criticism. Lilly received the voucher as part of its deal with the White House to cut obesity-drug prices in certain settings. Agency insiders have described the voucher program as open to political interference.10 Reuters also reported that Lilly pressed the FDA for a quicker answer on whether its applications were complete. Lilly said it expected a full, science-based review.10

The EMA's process gives a useful contrast. Europe followed its normal committee procedure and arrived at the same conclusion about Foundayo's benefits and risks. That does not settle the debate over the voucher program. It does make it harder to argue that the American approval was based on weak science.

Prices: the US model won't cross the Atlantic

In the US, Foundayo's price is the result of political bargaining. Self-pay patients pay $149 a month for the lowest dose and up to $349 for the highest. Commercially insured patients can pay as little as $25 with a savings card, and some Medicare Part D patients pay $50 a month.14 Lilly originally signalled cash prices up to $399. It cut that to a $299 ceiling for patients who refill continuously, after Novo launched its Wegovy pill at up to $299.10

Prices have fallen sharply across the US market. Wegovy and Zepbound launched at about $1,000 a month at pharmacies. They now sell on company websites from roughly $149 to $299, partly because of the deal with the Trump administration.22 In July, a Medicare bridge program set a $50 monthly copay for all weight-loss drugs. Investors say that removed much of the price advantage the Wegovy pill had at launch.23

Europe works differently. After Commission approval, each EU member state decides separately on price and reimbursement, based on the drug's role in its own health system.13 So no single European launch is coming. Instead, Lilly faces a series of national negotiations, and many European payers have been reluctant to pay for obesity treatment at all. Lilly said earlier this year that it expected to launch orforglipron in most international markets in 2027.21 The CHMP opinion fits that schedule, but reimbursement decisions will determine how quickly patients actually get the drug.

Sales: Novo leads in pills, Lilly leads overall

So far, the oral market belongs to Novo. The Wegovy pill brought in about $850 million worldwide in the first half of 2026. Foundayo, which launched later, made $98 million, all of it in the second quarter.11 That Foundayo figure missed analyst forecasts of about $104 million to $105.6 million.2325 The Wegovy pill also missed estimates for the quarter, with sales of about $494 million to $497 million.2325 Novo has captured more than 80% of new oral obesity prescriptions in the US, according to market researchers.11

The pill race is a small part of the overall picture. In the second quarter, Lilly's revenue rose 48% to nearly $23 billion.25 Mounjaro sales jumped 91% to $9.94 billion and Zepbound brought in $4.93 billion. Together the two drugs made up almost 65% of Lilly's revenue.23 Lilly then raised its 2026 revenue forecast to $85 billion to $87 billion.23

The reporting disagrees on how much pills matter. One market estimate says oral therapies make up about a third of US obesity prescriptions.11 Lilly's CFO, however, said injectables still account for about three of every four new patient starts.23 The more convincing reading is that pills are growing the market more than they are taking patients from injections. That matches early US data showing pills can attract people who would not use a needle.14 It also suggests that, for Lilly, Foundayo's value lies in bringing in new patients and keeping existing ones on treatment. A study cited at approval found it helped patients keep weight off after switching from injections.5

Why it matters beyond obesity

The same CHMP meeting also recommended Revolution Medicines' Rasonque (daraxonrasib) for adults with metastatic pancreatic cancer who have already been treated. That review was fast-tracked under the EMA's Cancer Medicines Pathfinder project.16 Obesity drugs drew the business headlines, but regulators are still giving priority to areas of high unmet need, such as cancers with few treatment options.

Forecasts for the overall market have become less certain. Reuters reports expectations that the obesity market will pass $100 billion by 2030.14 IQVIA put global sales at $66 billion in 2025.23 The older Wall Street target of $150 billion within a decade now looks shakier, because price cuts are eating into revenue per patient.22

In that setting, the European recommendation is a strategic gain for Lilly more than a near-term sales driver. It ends Novo's period as the only oral GLP-1 for obesity in Europe. It brings an oral challenger to Rybelsus in diabetes. And it lets Lilly sell Foundayo's no-fasting dosing to health systems that pay close attention to adherence. Novo still leads in pills, and European reimbursement will be slow and fragmented. But Lilly already dominates injectables and now has a pill cleared on both sides of the Atlantic, which leaves Novo with less room to compete.