- The UK is the first European country to approve Eli Lilly’s Foundayo pill.
- The tablet is taken once a day without food or water restrictions.
- NHS availability will depend on a separate NICE assessment.
The UK has become the first European nation to approve a new daily weight-loss pill, giving patients another option beyond the injectable treatments that have dominated the GLP-1 market.
The Medicines and Healthcare products Regulatory Agency (MHRA) approved Eli Lilly’s orforglipron, sold under the brand name Foundayo, on August 10 for weight management and to improve blood sugar control in adults with type 2 diabetes.
But there is an important catch for UK patients. MHRA approval does not mean Foundayo is available on the NHS. The medicine will now need to be assessed by the National Institute for Health and Care Excellence (NICE), which will decide whether it should be recommended for NHS use.
That leaves the UK in an unusual position. It has moved ahead of the rest of Europe on regulatory approval, but access through the health service is still undecided.
A new pill enters the GLP-1 race
Foundayo belongs to the GLP-1 class of medicines, which work on the body's appetite and blood sugar regulation systems. It is authorised for adults with a body mass index (BMI) of 30 or above, as well as those with a BMI between 27 and 30 who have at least one weight-related health condition.
For people with type 2 diabetes, it can also be used where blood sugar is not adequately controlled.
The main difference is that there is no injection involved. Foundayo is taken once a day and, unlike some existing oral GLP-1 medicines, it does not require patients to take it at a particular time in relation to food or follow specific water restrictions.
That could make the treatment easier to fit into everyday routines, although convenience is only part of the question. Patients and doctors will also have to weigh up its effectiveness, side effects and cost.
The MHRA said it had assessed the medicine for safety, quality and effectiveness before authorising it. Julian Beach, the agency’s executive director of healthcare quality and access, said the UK was the first regulator in Europe to authorise the tablet for weight management and type 2 diabetes.
Like other GLP-1 medicines, Foundayo is prescription-only. Reported side effects include nausea, constipation, diarrhoea, vomiting, indigestion and abdominal discomfort.
The approval comes just two months after the MHRA authorised Novo Nordisk’s tablet version of Wegovy, meaning the UK is now at the centre of a growing shift towards oral GLP-1 treatments.
For Eli Lilly, the move also puts Foundayo into direct competition with Novo Nordisk’s growing range of weight-loss treatments. The two companies have been competing for a larger share of the rapidly expanding obesity-drug market, which has so far been dominated by injectable medicines.
Approval is not the same as NHS access
For patients watching the development, the next question is straightforward: when can they actually get the pill?
Foundayo is not currently available through the NHS. The separate NICE assessment will determine whether it can be routinely offered through the health service. Private access is expected to come first, with the drug due to launch through private prescriptions later in August, according to Reuters.
The distinction between regulatory approval and NHS availability is important. The MHRA decides whether a medicine can legally be used in the UK after assessing its safety, quality and effectiveness. NICE considers whether treatments represent value for money for the NHS.
So, while Britain has won the race to approve Foundayo in Europe, patients may still have to wait before the NHS decides whether it will pay for the treatment.
For now, the UK has opened the door to another form of GLP-1 treatment. Whether that door leads to widespread NHS access will depend on the next stage of the process.
