UK Approves Once‑Weekly Basal Insulin Onswik for Adults with Type 2 Diabetes

The U.K. medicines regulator has authorized Onswik, a once-weekly basal insulin for adults with type 2 diabetes, a move that could sharply reduce how often some patients need injections. The Medicines and Healthcare products Regulatory Agency, or MHRA, said Tuesday it had granted a U.K. marketing authorization for Onswik, whose active ingredient is insulin efsitora alfa. The agency said the long-acting insulin is given by subcutaneous injection once a week and could cut injections for some people “from up to 365 a year to 52.”

The approval matters because daily basal insulin has long been the standard for many people with type 2 diabetes who need insulin to control blood sugar. MHRA said its review of the evidence found that once-weekly insulin efsitora alfa provided glycemic control comparable to once-daily basal insulin treatments in adults with type 2 diabetes. The agency said the most common adverse reaction reported with insulin efsitora alfa is hypoglycemia, or low blood sugar, and advised patients and clinicians to report suspected side effects through the U.K.’s Yellow Card safety monitoring scheme.

“This authorisation follows a rigorous assessment of the available evidence,” Julian Beach, MHRA executive director of healthcare quality and access, said in a statement. “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 authorization was granted to Eli Lilly Nederland B.V. through the Access work-sharing procedure. MHRA said the decision was supported by the Phase 3 QWINT clinical trial program, spanning QWINT-1 to QWINT-4, which enrolled more than 3,000 people with type 2 diabetes. Across those studies, insulin efsitora alfa produced reductions in HbA1c — a measure of average blood sugar over time — that were comparable to daily basal insulin comparators.

The approval also connects to an earlier step on potential patient access. On Aug. 20, the National Institute for Health and Care Excellence, or NICE, which evaluates treatments for use in the NHS in England, published final draft guidance recommending insulin efsitora alfa as an option for certain adults with type 2 diabetes, subject to MHRA licensing. That licensing has now been granted, although the draft guidance did not amount to confirmation of immediate nationwide NHS rollout.

NICE said weekly dosing could make the biggest practical difference for people who depend on a carer, family member or health professional to help with injections. That matters in a country where diabetes is common: NICE said 4.6 million people were diagnosed with diabetes in 2023-24, and about 90% of them had type 2 diabetes.

The U.K. decision places Onswik among a small but growing class of once-weekly basal insulins. In June, the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a positive opinion on the medicine, and the U.S. Food and Drug Administration approved Onswik on Sept. 23, describing it as the second once-weekly insulin approved for adults with type 2 diabetes.