FDA approves, expands label for Eli Lilly’s rapid-acting insulin for infusion

Eli Lilly (NYSE:LLY) announced today that it received FDA approval and expanded labeling for its Lyumjev rapid-acting insulin.

Indianapolis-based Eli Lilly’s Lyumjev (insulin lispro-aabc injection) 100 units/mL holds indication to improve glycemic control in adults with type 1 and type 2 diabetes, including administration via continuous subcutaneous insulin infusion (CSII) with an insulin pump.

The company designed Lyumjev as a novel formulation of insulin lispro for speeding up the absorption of insulin into the bloodstream and reduce A1C levels, helping to control blood sugar levels after meals in adults with diabetes in a manner similar to how natural insulin works in those without diabetes. It received FDA approval in June 2020.

Approval came on the back of results from the Pronto-Pump-2 phase 3 trial that demonstrated efficacy and safety for Lyumjev when used in insulin pumps in adults with type 1 diabetes. The study met the primary endpoint of non-inferior A1C reduction from baseline to week 16 when compared to Humalog, while also demonstrating superior reduction in blood glucose spikes at one and two hours after a test meal, again compared to Humalog.

“Insulin pumps are an important delivery option for people with diabetes – many of whom struggle with high postmeal blood sugar levels,” Lilly VP of medical affairs Dr. Leonard Glass said in a news release. “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.”

Original Article: (https://www.drugdeliverybusiness.com/fda-approves-expands-label-for-eli-lillys-rapid-acting-insulin-for-infusion/)