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.
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published final draft
guidance recommending insulin efsitora alfa as an option for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 to editors
-
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.
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For more information about type 2 diabetes, visit: Type 2
diabetes - NHS
