U.S. approval of pump use for Lilly’s novel insulin is latest development designed to help people with diabetes manage blood sugar levels
INDIANAPOLIS, Aug. 16, 2021 /PRNewswire/ — The U.S. Food and Drug Administration (FDA) has approved an expanded label for Eli Lilly and Company’s (NYSE: LLY) rapid-acting insulin, Lyumjev® (insulin lispro-aabc injection) 100 units/mL indicated to improve glycemic control in adults with type 1 and type 2 diabetes, to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump.
Lyumjev, a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020. As a rapid-acting mealtime insulin, Lyumjev helps control blood sugar levels after meals in adults with diabetes, similar to how natural insulin works after meals in people without diabetes.
“Insulin pumps are an important delivery option for people with diabetes – many of whom struggle with high postmeal blood sugar levels,” said Leonard Glass M.D., F.A.C.E., vice president of Medical Affairs, Lilly. “The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes. It is an exciting development for pump users seeking to manage their blood sugar levels and reduce postmeal spikes.”
The approval was based on results from PRONTO-PUMP-2, a phase 3 treat-to-target study that confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with type 1 diabetes. The study met the primary endpoint of noninferior A1C reduction from baseline to week 16 compared to Humalog. Lyumjev demonstrated superior reduction in blood glucose spikes at both one and two hours after a test meal compared to Humalog.1
Lyumjev is available in the U.S. and in several global markets, including Japan and the European Union, where it is also approved for use in insulin pumps. People with diabetes should seek guidance from their healthcare providers and refer to the insulin pump maker instructions to see if Lyumjev U-100 can be used with their pump.
Lilly offers several solutions to help eligible people who need assistance accessing their Lilly insulin, including Lyumjev, at the Lilly Diabetes Solution Center at (833) 808-1234 and www.insulinaffordability.com. People who have commercial insurance can visit www.Lyumjev.com to access the Lyumjev Savings Card. Lyumjev is also included in the Lilly Insulin Value Program for people with commercial insurance or no insurance at all, as well as in the Seniors Savings Model for people in the Medicare Part D program—allowing them to fill their monthly prescription of Lyumjev for $35. Other restrictions may apply.
About the PRONTO-PUMP-2 Study
PRONTO-PUMP-2 was a phase 3, 16-week, randomized (1:1), active controlled, double-blind treat-to-target multinational study that evaluated the efficacy and safety of Lyumjev versus Humalog (insulin lispro injection) 100 units/mL in 432 adult patients with type 1 diabetes (T1D) using insulin pumps. Following a 2-week lead-in period, patients were randomized in a double-blind manner to either Lyumjev (n=215) or Humalog (n=217), both 100 units/mL. Patients were instructed to deliver bolus doses 0-2 minutes before meals. The primary objective was noninferiority (noninferiority margin [NIM]=0.4% for A1C) of Lyumjev to Humalog on change in A1C from baseline to week 16. Key multiplicity-adjusted secondary objectives included superiority of Lyumjev to Humalog at week 16 for 1- and 2-hour postprandial glucose during a meal test and duration of time in range (70-180 mg/dL) during daytime and over a 24-hour period.1
- Warren, Mark, et al. Improved postprandial glucose control with ultra rapid lispro versus lispro with continuous subcutaneous insulin infusion in type 1 diabetes: PRONTO-Pump-2. Diabetes, Obesity and Metabolism. 2021; 23(7): 1552-1561.
- Centers for Disease Control and Prevention. National Diabetes Statistics Report, 2020. Atlanta, GA: Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services; 2020.
- International Diabetes Federation. IDF Diabetes Atlas, 9th edn. Brussels, Belgium: International Diabetes Federation, 2019. Available at: http://diabetesatlas.org.