FDA Approves Weekly Insulin Onswik for Type 2 Diabetes Patients

The U.S. Food and Drug Administration (FDA) has approved Onswik (efsitora alfa-gobe insulin), a long-acting basal insulin administered via a single weekly subcutaneous injection, as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. This marks the second weekly insulin approved for adults with the condition in the U.S., following Novo Nordisk's Awiqli. For patients currently administering daily basal insulin injections, this approval signifies a potential reduction from approximately 365 injections per year to just 52.

The weekly injection regimen replaces only basal insulin, not mealtime insulin. Individuals using short-acting insulin before meals will continue their existing injection schedule for that medication. In Israel, as of 2023, approximately 696,000 individuals aged two and above, representing about 7.4% of the population, were registered as having diabetes. Among those aged 65 and older, one-third live with the disease. Type 2 diabetes accounts for roughly 95% of all diabetes cases.

Awiqli, the first weekly insulin approved in the U.S., is anticipated to be available in Israel in November. The arrival date for Onswik in Israel has not yet been determined. Onswik has already received regulatory approval in the European Union, Mexico, and Japan.

The FDA's approval is based on four Phase 3 studies within the QWINT program, involving over 3,400 adults with type 2 diabetes. These studies included participants who were treatment-naive, those on daily basal insulin, and those on both basal and mealtime insulin. In these trials, Onswik, administered weekly, demonstrated comparable efficacy to daily insulins like glargine or degludec in reducing hemoglobin A1c levels, indicating it was not inferior. The time spent within the target blood glucose range was also similar across the groups.

Onswik is indicated for adults with type 2 diabetes and is not recommended for individuals with type 1 diabetes due to an increased risk of severe hypoglycemia. As with all insulins, the most common side effect is hypoglycemia. Other frequent adverse events include allergic reactions, injection site reactions, changes in subcutaneous fat tissue, itching, rash, swelling, and weight gain. The drug's label also includes warnings regarding medication errors, accidental overdose, hypokalemia, fluid retention, and heart failure when used concurrently with certain thiazolidinedione (TZD) medications. Rotating injection sites is advised. The drug's safety during pregnancy and breastfeeding is unknown, and it is therefore not recommended for use in these populations.