The Food and Drug Administration (FDA) has expanded the approval for Lyumjev® (insulin lispro-aabc injection) U-100 (100 Units/mL) to include administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump to improve glycemic control in adults with type 1 and type 2 diabetes. Previously, the treatment was approved for use by either intravenous infusion by a health care professional or by subcutaneous multiple daily injection.
Lyumjev is a novel formulation of insulin lispro designed to rapidly reduce glucose levels after meals. The expanded approval was based on data from the phase 3 PRONTO-PUMP-2 trial (ClinicalTrials.gov Identifier: NCT03830281) that compared the efficacy of Lyumjev to Humalog for insulin pump therapy in 432 adults with type 1 diabetes. Patients were randomly assigned 1:1 to receive either Lyumjev or Humalog, both 100 Units/mL via CSII, with mealtime bolus doses administered 0 to 2 minutes prior to the start of each meal.
Results showed that at week 16, treatment with Lyumjev provided a mean reduction in HbA1c that met the prespecified noninferiority margin (0.4%) compared with mealtime Humalog (estimated treatment difference vs Humalog: 0.03% [95% CI, -0.05, 0.11]). Lyumjev was also found to be superior to Humalog in controlling postprandial glucose levels at 1 and 2 hours after the meal test.
“Insulin pumps are an important delivery option for people with diabetes, many of whom struggle with high postmeal blood sugar levels,” said Leonard Glass MD, FACE, 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.”
Lyumjev is also available as 200 Units/mL; this strength is not approved for use in insulin pumps.
- FDA approves Lyumjev® (insulin lispro-aabc injection) 100 units/mL for use in insulin pumps. News release. Eli Lilly and Company. Accessed August 16, 2021. https://www.prnewswire.com/news-releases/fda-approves-lyumjev-insulin-lispro-aabc-injection-100-unitsml-for-use-in-insulin-pumps-301355407.html.
- Lyumjev [package insert]. Indianapolis, IN: Eli Lilly and Company; 2021.