FDA Approves Insulin Lispro-aabc Injection for Insulin Pump Use

The US Food and Drug Administration (FDA) has approved an expanded label for insulin lispro-aabc injection 100 units/mL (Lyumjev) to include administration via continuous subcutaneous insulin infusion with an insulin pump.

The approval was granted to Eli Lilly and Company to improve glycemic control in adult patients with type 1 or type 2 diabetes.

Treatment

The agent is a novel formulation of insulin lispro developed to speed absorption of insulin into the bloodstream and reduce A1C levels.

Due to its formulation as a rapid-acting mealtime insulin, the treatment controls blood sugar levels after meals in the targeted population of adults with diabetes.

The insulin lispro-aabc injection was approved by the FDA in 2020 based on results from the PRONTO-PUMP-2 study.

The phase 3 treat-to-target study met the primary endpoint of noninferior A1C reduction from baseline to week 16 compared to Insulin lispro injection (Humalog).

In addition, there was significant reduction in blood glucose spikes at 1- and 2-hours after a test meal with insulin lispro-aabc injection in comparison to insulin lispro injection.

Reaction

Leonard Glass, MD, vice president of Medical Affairs, Lilly noted in a statement the importance of the expanded insulin pump delivery option for people with diabetes.

"The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes,” Glass said. “It is an exciting development for pump users seeking to manage their blood sugar levels and reduce post meal spikes."