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

August 16, 2021 By Sean Whooley

Eli LillyEli 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 over time. Lilly said the insulin can help 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 the company’s Humalog insulin, 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.”

Filed Under: Auto-injectors, Diabetes, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Eli Lilly, Eli Lilly & Co., FDA, Lyumjev, rapid-acting insulin

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at swhooley@wtwhmedia.com.

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