MHRA licenses Lilly's once-weekly insulin Onswik, meeting NICE's condition for NHS use
The 13 October authorisation for adults with type 2 diabetes meets the licensing condition NICE attached to its August final draft guidance.
By World Pharma AI Editorial
The Medicines and Healthcare products Regulatory Agency (MHRA) granted a UK marketing authorisation on 13 October 2026 for Onswik (insulin efsitora alfa), Eli Lilly's long-acting basal insulin given by injection once a week, for adults with type 2 diabetes 1. The licence went to Eli Lilly Nederland B.V. through the ACCESS procedure 1.
What the regulator and NICE decided
The MHRA said the move from daily to weekly dosing may cut the injections some patients need from up to 365 a year to 52 1. Julian Beach, the agency's Executive Director of Healthcare Quality and Access, said trial data showed the weekly product gave "glycaemic control comparable to once-daily basal insulin treatments in adults with type 2 diabetes" 1. Hypoglycaemia is the adverse reaction reported most often, and the agency said it will keep the medicine's safety under watch through its surveillance systems 1.
The licence completes a sequence that began in August. NICE issued final draft guidance on 20 August 2026 recommending insulin efsitora alfa for certain adults with type 2 diabetes, on condition that the MHRA licensed it first 2. The MHRA confirmed that this condition has now been met 1. NICE based its view on trial evidence that the weekly insulin controls blood glucose as well as insulin degludec and insulin glargine, two long-acting insulins in wide use 2. It put the reduction in injections per patient at 85% and said the product can be used on its own or with other type 2 diabetes treatments 2.
What it means for the market
The scale of the potential UK market is large. NICE cited 4.6 million people in the UK with diagnosed diabetes in 2023-24, around 90% of them with type 2 diabetes, and said hundreds of thousands could move to the weekly jab 2. The groups NICE expects to gain most are patients who depend on carers, district nurses or other staff to inject them, including frailer people and those with sight loss, limited hand movement or learning disabilities 2. For NHS providers, fewer injection visits is the operational case, since it means fewer home visits by carers or healthcare workers 2. NICE also pointed to people under 40 with early-onset type 2 diabetes who combine intensive treatment with work 2.
The guidance does not give the product a free run against daily insulins. NICE told clinicians and patients to weigh the suitable options and pick the least expensive one that meets the person's needs, counting dosage, administration costs and price 2. Price and administration costs therefore decide, case by case, whether the weekly product or an existing basal insulin is prescribed 2. Neither source gives the NHS list price. Helen Knight, NICE's director of medicines evaluation, described the decision as balancing patient benefit against "the best use of limited NHS funding" 2.
Diabetes UK's Douglas Twenefour said any NHS rollout should come with clear guidance, staff training and fair access 2.
Caveats
The evidence both bodies cite is about glucose control being comparable to daily insulins, not better 12. The licence covers adults with type 2 diabetes only 1. The full Summary of Product Characteristics and Patient Information Leaflet, which will set out dosing and precautions in detail, have not yet been published and will appear on the MHRA Products website in due course 1.
References
This briefing summarises publicly available research and reporting for information only. It is not medical, investment or legal advice. Follow the references to the primary sources.