September 24, 2021

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New fast-acting insulin: FDA approved Eli Lilly Lyumjev label expansion

New fast-acting insulin: FDA approved Eli Lilly Lyumjev label expansion.

New fast-acting insulin! FDA approved Eli Lilly Lyumjev (Insulin lispro)  label expansion: continuous subcutaneous insulin infusion (CSII) administration through an insulin pump!

New fast-acting insulin: FDA approved Eli Lilly Lyumjev label expansion.  Lyumjev is a fast-acting meal insulin, which can accelerate the absorption of insulin into the blood and reduce the blood glucose level after meals.

Eli Lilly recently announced that the U.S. Food and Drug Administration (FDA) has approved the rapid-acting insulin product Lyumjev® (insulin lispro-aabc injection, insulin lispro injection) Solution) 100 units/ml label expansion, including: continuous subcutaneous insulin infusion (CSII) administration through an insulin pump to improve blood glucose control in adult patients with type 1 and type 2 diabetes.

Lyumjev is a new insulin lispro preparation designed to accelerate the absorption of insulin into the blood and reduce A1C levels. The product was approved by the FDA in June 2020. As a fast-acting prandial insulin, Lyumjev helps to control the postprandial blood sugar level of diabetic adults, similar to the working principle of natural insulin after a meal in non-diabetic people.

This approval is based on the results of the PRONTO-PUMP-2 study. This is a phase 3 treat-to-target study, confirming the efficacy and safety of Lyumjev in the treatment of adult patients with type 1 diabetes through insulin pump administration. The study reached the primary endpoint: from the baseline check to week 16, Lyumjev showed non-inferiority in reducing A1C compared with Humalog. At 1 hour and 2 hours after the test meal, Lyumjev and Humalog had significantly lower blood glucose peaks.

Leonard Glass, Vice President of Eli Lilly Medical Affairs, said: “Insulin pumps are an important drug delivery option for diabetic patients, many of whom are struggling with high blood sugar levels. The Lyumjev label extension includes the use of insulin pumps. It provides a new and important option for diabetics. This is exciting news for diabetics who use insulin pumps to manage blood sugar levels and reduce blood sugar spikes after meals.”

Lyumjev is available in the United States and several global markets, including Japan and the European Union, where the product is also approved for use in insulin pumps. Diabetes patients should seek guidance from their healthcare provider and refer to the insulin pump manufacturer’s instructions to determine whether Lyumjev U-100 can be used in their insulin pump

(source:internet, reference only)


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