US FDA approves Lilly's weekly insulin shot for type 2 diabetes

• Onswik (insulin efsitora alfa-gobe) could reduce the number of injections by more than 300 per year compared to once-daily basal insulin treatments
• Late-stage trials across four studies demonstrated A1C reductions non-inferior to daily insulin glargine (sold as Sanofi's Lantus and Lilly's Basaglar)
• The drug should not be used in type 1 diabetes patients due to increased risk of severe hypoglycemia; it will be available as a pre-filled KwikPen in 500 and 1,000 units per milliliter concentrations

Summary: FDA Approves Eli Lilly's Weekly Insulin for Type 2 Diabetes

Key Development:

The U.S. FDA has approved Eli Lilly's Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin injection for adults with type 2 diabetes, announced September 24. The treatment will be available in the U.S. within the coming months.

Product Details:

• Onswik will be sold as a pre-filled KwikPen in two concentrations: 500 units/mL and 1,000 units/mL
• Reduces injection frequency by more than 300 injections annually compared to daily basal insulin
• Intended for use alongside diet and exercise to control high blood sugar
• Not approved for type 1 diabetes due to increased risk of severe hypoglycemia

Clinical Data:

The approval was based on late-stage trials involving over 3,400 adults across four studies. Onswik demonstrated non-inferior A1C (blood sugar measure) reductions compared to daily basal insulins like insulin glargine (Sanofi's Lantus and Lilly's Basaglar).

Market Context:

• Onswik has previously received regulatory approvals in Europe, Japan, and Mexico
• Competing product: Novo Nordisk's Awiqli, a weekly insulin approved by the FDA in March for type 2 diabetes

Market Implications:

This approval strengthens Lilly's position in the diabetes treatment market, offering a more convenient alternative to daily injections. The once-weekly dosing could improve patient compliance and compete directly with Novo Nordisk's similar offering, intensifying competition in the evolving insulin market segment focused on patient convenience.