Foundayo UK approval gives Eli Lilly its first authorization outside the U.S.
Britain has authorized Lilly’s daily Foundayo pill for weight management and type 2 diabetes, but NHS access is still pending.
By Theo Nakamura · Staff Writer
· 3 min read
Eli Lilly’s Foundayo UK approval gives the drugmaker its first authorization for the daily pill outside the U.S. For investors watching the obesity-drug race, the decision opens a path to private prescribing in Britain, though it does not mean the medicine is available through the National Health Service.
Britain’s Medicines and Healthcare products Regulatory Agency authorized Foundayo, also called orforglipron, on Aug. 10 for weight management and type 2 diabetes, Reuters and The Pharmaceutical Journal reported. The decision makes the UK the first country in Europe to authorize the treatment for both uses.
Foundayo is the second GLP-1 weight-loss pill authorized in the UK. Novo Nordisk’s tablet version of Wegovy received UK authorization in June, according to Reuters.
Who can get Foundayo in the UK?
For weight management, the authorization covers adults with a body mass index of at least 30, or those with a BMI from 27 to under 30 who also have at least one weight-related condition. It is authorized alongside a reduced-calorie diet and increased physical activity, The Pharmaceutical Journal reported.
The medicine is also authorized to improve glycaemic control in adults whose type 2 diabetes is insufficiently controlled, according to the publication.
Authorization and NHS availability are separate steps. The MHRA said Foundayo is not currently available through the NHS. NICE, the body that evaluates treatments for NHS use, is developing guidance on Foundayo for overweight and obesity, The Pharmaceutical Journal reported. Its guidance is due on Nov. 18.
A Lilly spokesperson told Reuters that the company expects to launch Foundayo later in August through private prescriptions. The spokesperson said its private UK list price would be below Mounjaro’s £330 monthly list price, without disclosing Foundayo’s price.
How does Foundayo differ from the Wegovy pill?
The most visible difference is the dosing routine. Foundayo is a once-daily tablet that can be taken without food or water restrictions, according to Lilly and Reuters. Wegovy’s pill must be taken in the morning on an empty stomach with a small amount of water, followed by a 30-minute wait before food, drinks or other medicines.
The companies also point to different clinical data, but they have not run a head-to-head trial. BioPharma Dive reported that Foundayo produced about 11% average weight loss at its highest dose in a trial of people with obesity without diabetes, while Wegovy’s pill produced about 14% in a separate study. Those results cannot establish that either drug works better than the other.
Foundayo launched in the U.S. in April after Food and Drug Administration approval. Lilly said its ATTAIN-1 trial found 12.4% average weight loss among participants who remained on the highest dose, compared with placebo, though that result came from the company’s own release.
Like other prescription medicines, Foundayo carries safety considerations. Lilly’s prescribing information warns of a thyroid-tumor risk and lists nausea, constipation, diarrhea, vomiting and abdominal pain among common side effects. The company has also submitted the drug for approval in more than 40 countries, while Reuters reported it remains under review in the European Union.
This story draws on original reporting from CNBC.
