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Lyumjev (insulin lispro-aabc) Injection Approved by U.S. FDA for Children with Diabetes

October 14, 2022 -- The U.S. Food and Drug Administration (FDA) approved an expansion of the indication for Eli Lilly and Company's rapid-acting mealtime insulin Lyumjev® (insulin lispro-aabc) injection to include the improvement of glycemic control in children with diabetes. Lyumjev can be administered subcutaneously either at the start of a meal or within 20 minutes after starting a meal, or as a continuous subcutaneous insulin infusion (CSII) with an insulin pump.

The FDA approval was based on results from PRONTO-Peds, a phase 3, randomized, treat-to-target study that evaluated Lyumjev (100 units/mL) dosed at mealtime and post-mealtime (up to 20 minutes after the start of a meal) compared to Humalog® (insulin lispro) injection 100 units/mL in children and adolescents with diabetes. The study met the primary endpoint of noninferior A1C change from baseline to week 26 of Lyumjev compared to Humalog, both dosed at mealtime.1

Lyumjev was first approved by the FDA in June 2020 to improve glycemic control in adults with type 1 and type 2 diabetes and an expanded label was approved in August 2021 to include administration via CSII with an insulin pump. Lyumjev is available for adults in several global markets, including the U.S., EU and Japan. Additionally, on October 13, 2022, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion to extend the indication of Lyumjev for the treatment of children with diabetes aged 1 year and older on – an important step toward European approval.

Lilly offers several options to help eligible people who need assistance affording their Lilly insulin, including Lyumjev, at the Lilly Diabetes Solution Center at 1-833-808-1234 and www.insulinaffordability.com. People who have commercial insurance can visit www.Lyumjev.com to access the Lyumjev Savings Card. Lyumjev is also included in the Lilly Insulin Value Program for people with commercial insurance or no insurance at all, as well as in the Seniors Savings Model for people in the Medicare Part D program—allowing them to fill their monthly prescription of Lyumjev for $35. Other restrictions may apply.

Lyumjev is available in two strengths: U-100 (100 units/mL) and U-200 (200 units/mL).

Source: Eli Lilly and Company

Posted: October 2022

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