FDA Approves Expanded Label for Lilly’s Lyumjev

According to an August 16, 2021 press release, FDA approved an expanded label for Eli Lilly's rapid-acting insulin, Lyumjev (insulin lispro-aabc injection) 100 units/mL to include administration through continuous subcutaneous insulin infusion (CSII) with an insulin pump. Lyumjev is a formulation of insulin lispro—developed to speed the absorption of insulin into the bloodstream and reduce A1C levels—and is indicated to improve glycemic control in adults with type 1 and type 2 diabetes. It was approved by FDA in June 2020.

Results from PRONTO-PUMP-2, a phase III study, was what FDA approval was based on. The study confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with type 1 diabetes. Lyumjev is available in the United States and select global markets, including Japan and the European Union.

"Insulin pumps are an important delivery option for people with diabetes—many of whom struggle with high postmeal blood sugar levels," said Leonard Glass, 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."