The MHRA Authorised Two Obesity Drugs in Two Days. Neither Is on the NHS.
- On 11 August 2026 the MHRA expanded the marketing authorisation for IMCIVREE (setmelanotide) to cover acquired hypothalamic obesity caused by hypothalamic injury or impairment, in adults and children aged 4 and over, and granted orphan designation for the indication. Rhythm’s MC4R agonist was already authorised from age 2 for Bardet-Biedl syndrome and POMC, PCSK1 or LEPR deficiency.
- One day earlier the MHRA authorised Eli Lilly’s Foundayo, an oral GLP-1, for weight management and type 2 diabetes, making the UK the first European market to clear the pill for both. The regulator stated plainly that the tablet is not currently available via the NHS.
- Lilly will launch in the UK later this month by private prescription, at a list price the company says will sit below Mounjaro’s £330 per month, without disclosing the figure. It is the second oral GLP-1 cleared in the UK after Novo Nordisk’s Wegovy pill in June.
- The IMCIVREE expansion rests on the Phase 3 TRANSCEND trial in 142 patients, which produced a placebo-adjusted BMI reduction of 18.4%, published in the New England Journal of Medicine. Rhythm reported Q2 IMCIVREE revenue of $71.3 million and more than 400 US patient start forms since the March FDA approval.
Two MHRA decisions · two different access problems
| IMCIVREE (Rhythm) | Foundayo (Eli Lilly) | |
|---|---|---|
| Decision | Expanded authorisation, 11 Aug | New authorisation, 10 Aug |
| Population | Acquired hypothalamic obesity, age 4 and over | BMI 30 and over, or 27 to 30 with comorbidity, and type 2 diabetes |
| Obesity type | Lesion-driven, with severe hyperphagia | Common polygenic |
| Form | Daily injection | Daily oral tablet |
| Orphan status | Granted for acquired HO | Not applicable |
| NHS route | Rare disease commissioning | NICE review, private prescription first |
Populations as stated by the companies and the MHRA. Both products are authorised in the UK. Neither is routinely available on the NHS at the date of authorisation.
Access read
Two authorisations, two days, and the same gap after both. The MHRA said the quiet part out loud about Foundayo: approved for use in the UK, not currently available via the NHS. Lilly’s answer is to launch by private prescription later this month, priced under Mounjaro’s £330 a month, which means the first British market for an oral GLP-1 is people paying cash. IMCIVREE faces the same wall from the opposite side, needing rare disease commissioning for a population small enough that no volume argument exists. One drug is too common to fund and the other is too rare to prioritise.
- Private prescription is not a stopgap here, it is a pricing strategy. Selling below Mounjaro privately sets a public reference point before NICE opens its appraisal, and every month of cash-pay sales generates UK usage data that a manufacturer can carry into that process. It also builds a patient population already on therapy, which changes the character of an appraisal from whether to start funding something to whether to withdraw it. Watch what Lilly actually charges, because that number is doing negotiating work long before the committee sits.
- Competitive frame: these two are not in the same market, and conflating them is the error to avoid. Setmelanotide treats obesity caused by a damaged hypothalamus, where hyperphagia is the mechanism and an MC4R agonist restores a broken signalling pathway. Foundayo treats common polygenic obesity in millions of people. The reason they belong in one read is that both now sit in the same NHS queue, competing for the same constrained budget, and rare disease historically loses that contest on volume while winning it on unmet need. Rhythm’s protection is the orphan designation granted alongside the expansion, which is exactly the instrument built to stop a small population being crowded out.
- What to watch: the NICE appraisal for Foundayo, expected around November, and specifically whether any recommendation carries a commercial arrangement, as NICE has done repeatedly this month. Then watch the private channel itself, because a two-tier market in obesity medicine is forming in real time and the NHS decision will land on a population already partly self-funding. And note the direction of travel in Lilly’s own numbers: realised prices fell 13% worldwide in Q2 while volume rose 60%. Launching privately in the UK at a discount to your own injectable is the same trade in a different currency.
Read the original source (Rhythm Pharmaceuticals) →
MHRA authorisation of Foundayo (Reuters, via Euronext) →