Lilly's Foundayo pill wins EU committee backing for obesity and type 2 diabetes

Eli Lilly's once-daily weight-loss pill Foundayo has won the backing of the European Medicines Agency's drug committee, which recommended on Thursday that it be authorized in the European Union for weight management and for type 2 diabetes in adults. The European Commission, which makes the final decision, normally issues it 67 days after the committee's opinion, the agency said.

What the committee recommended

The European Medicines Agency's human medicines committee, known as the CHMP, adopted a positive opinion on Thursday, Oct. 15, recommending that the European Union authorize Foundayo, Eli Lilly's once-daily orforglipron tablet, for weight management and for type 2 diabetes in adults. The agency published the recommendation on Friday.

For weight management, the recommendation covers adults with a body mass index of 30 or more, or of 27 to under 30 with at least one weight-related condition such as prediabetes, type 2 diabetes, high blood pressure, abnormal blood fats, obstructive sleep apnoea or cardiovascular disease. The drug would be used alongside diet and physical activity. For type 2 diabetes, it covers adults whose blood sugar is not sufficiently controlled, either on its own when metformin is not appropriate or together with other diabetes medicines.

Foundayo would come in six tablet strengths, from 0.8 mg to 17.2 mg. Orforglipron is a small, non-peptide molecule that activates the GLP-1 receptor, and the agency said that is what allows it to be taken by mouth. Patients can take it at any time of day, with or without food, starting at a low dose that is raised gradually.

What the studies showed

The weight-management recommendation rests on two studies of 4,740 adults with obesity or overweight, one of them in people who also had type 2 diabetes. After 72 weeks, people taking Foundayo lost around 5% to 11% of their body weight, depending on the dose, compared with around 2% to 2.5% for those on placebo, the agency said.

For diabetes, the committee looked at four main studies in 3,765 adults. Foundayo lowered HbA1c, a marker of blood sugar control, by around 1.2 to 1.9 percentage points depending on the dose. Placebo lowered it by 0.4 to 0.8 points, dapagliflozin 10 mg by 0.8 points, and oral semaglutide by 1.2 to 1.5 points at doses of 7 mg and 14 mg.

The most common side effects were nausea, vomiting and diarrhoea. They were more frequent while the dose was being raised and became less frequent over time, according to the agency.

Where it fits against Novo's pills

If the European Commission follows the recommendation, Foundayo would be the second GLP-1 pill for weight management in the EU, after Novo Nordisk's Wegovy pill, which won EU approval in July for weight management only, according to pharmaphorum and PharmExec. In diabetes, it would compete with Novo's Rybelsus, an oral form of semaglutide sold in the EU since 2020.

Both Novo pills must be taken on an empty stomach, with a wait of at least 30 minutes before taking anything else, the trade publication pharmaphorum noted. Foundayo has no such restriction.

What it means for Lilly

Foundayo is still a small part of Lilly's business. The pill went on sale in the U.S. in April and in the U.K. in August, and Lilly has sought approval in more than 40 countries, Reuters reported. Its first reported quarterly sales, for the second quarter, were $98 million, against total company revenue of $23.0 billion. That is less than half of 1% of the quarter's revenue, by TickerGrove's calculation. By comparison, Mounjaro brought in $9.9 billion worldwide in the same quarter.

The European recommendation includes type 2 diabetes, a use for which Foundayo is still awaiting a U.S. decision. Lilly said in August that it had submitted orforglipron for type 2 diabetes in the U.S., and PharmExec reported on Friday that the application is still pending.

Lilly shares closed at $1,257.03 on Friday, up 0.4%.

What happens next

The committee's opinion is not an approval. The European Commission makes the final decision, which the agency says is normally issued 67 days after the opinion is adopted. That would be around Dec. 21, by TickerGrove's calculation. The detailed EU prescribing information will be published only after the Commission decides, and if the drug is authorized, pricing and reimbursement will be decided separately by each member state.