MHRA authorises Onswik for adults with type 2 diabetes

The Medicines and Healthcare products Regulatory Agency (MHRA) has today, 13 October 2026, authorised Onswik (insulin efsitora alfa) for the treatment of type 2 diabetes mellitus in adults.

Insulin efsitora alfa, a long-acting basal insulin, is administered via injection once weekly. For those with type 2 diabetes, this treatment option may reduce the number of injections required from up to 365 a year to 52.

Insulin helps regulate blood glucose levels by stimulating glucose uptake into muscle and fat cells and by reducing glucose production by the liver. It also inhibits the breakdown of fat and protein and promotes protein synthesis.

Type 2 diabetes is a long-term condition in which the body does not produce enough insulin, or the insulin it produces does not work properly. This results in high levels of glucose in the blood, which can lead to serious health complications if not adequately controlled.

Julian Beach, MHRA Executive Director of Healthcare Quality and Access, said:

“This authorisation follows a rigorous assessment of the available evidence.

“Clinical trial data showed that once-weekly insulin efsitora alfa provided glycaemic control comparable to once-daily basal insulin treatments in adults with type 2 diabetes.

“As with all medicines, we will continue to monitor its safety closely through our established surveillance systems.”

The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending insulin efsitora alfa as an option for certain adults with type 2 diabetes. NICE’s recommendation was subject to MHRA licensing, which has now been granted.

The most common adverse reaction reported with insulin efsitora alfa is hypoglycaemia (low blood sugar).

Anyone who suspects they are experiencing a side effect should speak to their doctor, pharmacist or nurse and report it directly through the Yellow Card scheme at https://yellowcard.mhra.gov.uk or via the MHRA Yellow Card app.

Notes

• The marketing authorisation was granted on 13 October 2026 to Eli Lilly Nederland B.V via ACCESS Procedure
• More information can be found in the Summary of Product Characteristics (SmPC) and Patient Information Leaflet (PIL), which will be published on the MHRA Products website in due course.
• For more information about type 2 diabetes, visit: Type 2 diabetes – NHS
• The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for regulating all medicines and medical devices in the UK by ensuring they work and are acceptably safe.  All our work is underpinned by robust and fact-based judgements to ensure that the benefits justify any risks.
• The MHRA is an executive agency of the Department of Health and Social Care.

source: GOV