Weekly Insulin Option Approved by FDA, Offering Alternative to Daily Injections

The U.S. Food and Drug Administration (FDA) has approved once-weekly insulin injections for adults with type 2 diabetes, marking a significant advancement in diabetes management. The new long-acting insulin, branded as Onswik by pharmaceutical company Eli Lilly, is designed to be administered just once a week, potentially reducing the number of annual injections by over 300 for patients.

Onswik is not the first weekly insulin to receive approval; it follows Awiqli, developed by Danish competitor Novo Nordisk, which was approved in the U.S. in March and in the European Union two years prior. Awiqli is expected to become available in Israel in November. The arrival date for Onswik in Israel remains uncertain.

These weekly injections are intended to replace basal insulin, the long-acting insulin that maintains a steady insulin level throughout the day, and not mealtime insulin. Type 2 diabetes affects approximately 95% of diabetes cases, characterized by the body's resistance to insulin and insufficient production by the pancreas, leading to elevated blood sugar levels that can damage organs over time. In Israel, around 696,000 individuals aged two and above had diabetes in 2023, representing 7.4% of the population.

Clinical trials involving over 3,400 adults with type 2 diabetes demonstrated that Onswik was as effective as daily basal insulins in controlling blood sugar levels, as measured by HbA1c. The duration of time blood sugar remained within the normal range was also comparable between the weekly and daily injection groups.

Common side effects associated with Onswik, similar to other insulin treatments, include hypoglycemia (low blood sugar), which can manifest as dizziness, tremors, anxiety, sweating, hunger, or confusion. Serious hypoglycemic events were rare. Other reported side effects include allergic reactions, weight gain, and skin changes at the injection site. The drug's label includes warnings about dosage errors, accidental overdose, potential drops in potassium levels, and fluid retention or heart failure when used with certain other medications. Its safety during pregnancy and breastfeeding is unknown, and it is not recommended for these conditions.

Both Onswik and Awiqli utilize different mechanisms to achieve their extended duration of action. Awiqli's active ingredient binds to albumin in the blood, creating a reservoir from which insulin is gradually released. Onswik's insulin is attached to a fragment of a human antibody, slowing its breakdown in the body and resulting in a half-life of 15 to 16 days. Both weekly insulins are also more concentrated than daily formulations.