Britain’s Medicines and Healthcare products Regulatory Agency (MHRA) has authorised Eli Lilly’s Onswik (insulin efsitora alfa) for the treatment of type 2 diabetes mellitus in adults.
The long-acting basal insulin is given via injection once weekly, and may reduce the number of injections required from up to 365 a year to 52.
Onswik was registered in the US by the FDA last month, but as yet has not been authorised by the South African Health Products Regulatory Authority (SAPHRA).
Julian Beach, MHRA executive director of Healthcare Quality and Access, said the authorisation in the UK 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The National Institute for Health and Care Excellence (NICE) has published final draft guidance recommending the treatment as an option for certain adults with type 2 diabetes.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).
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