FDA Approves Insulin Lispro-aabc Injection for Use in Insulin Pumps

The expanded indication follows Lyumjev’s original approval in 2020 and offers an important new delivery mechanism for patients with diabetes.

Lilly’s insulin lispro-aabc injection (Lyumjev) 100 units/mL has been granted FDA approval to improve glycemic control in adults with type 1 and type 2 diabetes, including administration via continuous subcutaneous insulin infusion with an insulin pump.

The injection is a novel formulation of insulin lispro that is designed to accelerate its absorption into the bloodstream, thereby reducing A1C levels. The drug was originally approved by the FDA in June 2020 as a rapid-acting mealtime insulin. The new, expanded label offers an important new delivery mechanism for patients with diabetes, according to a press release from Lilly.

“Insulin pumps are an important delivery option for people with diabetes—many of whom struggle with high post meal blood sugar levels,” said Leonard Glass, MD, FACE, vice president of medical affairs at Lilly, in the press release.

The new approval was based on results from the PRONTO-PUMP-2, a phase 3, 16-week, randomized treat-to-target multinational study evaluating the efficacy and safety of lispro-aabc versus Humalog, another insulin lispro injection. Following a 2-week lead-in period, trial participants were randomized to receive either drug and were instructed to deliver bolus doses between 0 and 2 minutes prior to meals.

The study met its primary endpoint of noninferior A1C reduction from baseline to week 16 compared to Humalog. Lispro-aabc also demonstrated superior reduction in blood glucose spikes at both 1 and 2 hours after a test meal.

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

REFERENCE

FDA approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps. News release. Lilly; August 16, 2021. Accessed August 16, 2021. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lyumjevr-insulin-lispro-aabc-injection-100-unitsml