The era of weight-loss injections could be facing a new challenge as Britain becomes the first European country to authorise a once-daily GLP-1 tablet that could be taken without needles, special meal timing or refrigeration.
Britain has become the first country in Europe to approve Eli Lilly’s new oral weight-management medicine, potentially opening a new chapter in the rapidly expanding market for obesity treatments.
The Medicines and Healthcare products Regulatory Agency authorised orforglipron, marketed as Foundayo, on 10 August for weight management and weight maintenance in adults, as well as for improving blood-sugar control in people with insufficiently controlled type 2 diabetes.
Unlike widely used injectable GLP-1 treatments, Foundayo is taken once a day as a tablet.
There is no requirement to take it at a particular time of day and the MHRA says it can be taken without food or water restrictions. Treatment begins at a low dose and is gradually increased under medical supervision.
That convenience could prove commercially important.
The weight-loss market has been transformed by medicines such as Wegovy and Mounjaro, but injections can be a barrier for some patients. An effective oral alternative could potentially bring GLP-1 treatment to people who are unwilling or unable to use injectable medicines.
A potentially enormous market
Foundayo is authorised for adults with a BMI of 30 or above, or adults with a BMI between 27 and 30 who have at least one weight-related health condition.
However, British consumers should not assume the tablet will immediately become an NHS treatment.
The MHRA’s authorisation means the medicine can legally be used in the UK within its approved indications. It does not mean that the NHS will automatically provide it.
NICE will now assess whether it should be recommended for NHS use. Until that process is completed, access will depend on prescribing arrangements, including private healthcare.
The MHRA has also stressed that Foundayo is a prescription-only medicine and warned consumers against buying GLP-1 medicines from unregulated sellers.
The next battle is commercial
For Eli Lilly, the authorisation is another major step in the battle to dominate the obesity-treatment market.
The attraction of an oral GLP-1 is obvious: no injection, simple daily administration and potentially easier distribution.
But it is not without side effects. The MHRA lists nausea, constipation, diarrhoea, vomiting, indigestion and abdominal pain among the most common adverse effects.
Britain’s decision could therefore have consequences far beyond the pharmaceutical sector.
If oral GLP-1 medicines become widely adopted, pharmacies, private healthcare providers, food companies, retailers, fitness businesses and consumer brands could all face changing consumer behaviour.
The weight-loss revolution has largely been driven by the injection.
Now Britain has opened the door to the pill.