Eli Lilly’s Foundayo (orforglipron) has secured UK regulatory approval for weight management and type 2 diabetes, making the UK the first European country to authorise the once-daily GLP-1 tablet
The MHRA cleared orforglipron on Monday, but it is not yet available through the NHS. Lilly now faces the next, higher-stakes step in its regulatory journey: a NICE health technology appraisal and a decision on NHS reimbursement
A new oral GLP-1 option
Orforglipron is a small-molecule, non-peptide GLP-1 receptor agonist. It is taken once daily and, unlike some oral peptide therapies, can be taken at any time of day without food or water restrictions
The phase 3 evidence points to a substantial reduction in body weight. In ATTAIN-1, 3,127 adults with obesity received orforglipron for 72 weeks. Mean weight loss was 11.2% at 36 mg, compared with 2.1% with placebo. At the same strength, 54.6% of participants achieved at least 10% weight loss. Gastrointestinal adverse events were the most common side effects, with most reported as mild to moderate
Efficacy extends to diabetes
The programme also showed meaningful glycaemic control in the phase 3 ACHIEVE-1 study. Among 559 people with early type 2 diabetes, HbA1c fell by 1.47 percentage points with 12 mg and 1.48 points with 36 mg at week 40, versus 0.41 points with placebo
Weight reduction was seen in the same cohort, with a 5.8% decline at 12 mg and 7.6% at 36 mg, compared with 1.7% for placebo. Most adverse events were mild to moderate gastrointestinal events and were concentrated during dose escalation
NHS access pending
The NICE decision on orforglipron for managing overweight and obesity is due on 18 November 2026. The appraisal will consider its clinical and cost effectiveness within the terms of its marketing authorisation
The UK launch places Lilly in direct competition with Novo Nordisk, whose oral Wegovy (semaglutide) is already approved in Britain. If NHS-approved, the two leading GLP-1 players will be competing in the same oral segment, with efficacy, tolerability, price and supply likely to shape prescribing and uptake
Featured image: Maxim on Adobe Stock
Author:
Isabel O’Brien
