Data from the Phase 3 randomised, active-controlled clinical studies PRONTO-T1D and PRONTO-T2D has supported the US regulatory approval of Lyumjev
Lyumjev will improve glycemic control in adults with type 1 and type 2 diabetes. (Credit: MultiVu.)
Eli Lilly and Company (Lilly) has received the US Food and Drug Administration (FDA) approval for its new rapid-acting insulin, dubbed Lyumjev (insulin lispro-aabc injection) to improve glycemic control in adults with type 1 and type 2 diabetes.
The pharmaceutical company has developed Lyumjev, a novel formulation of insulin lispro, for enhanced absorption of insulin into the bloodstream and reduce A1C levels.
Lilly said that the rapid-acting mealtime insulin Lyumjev will control high blood sugar levels after meals in adults with diabetes, resembling how natural insulin works after meals in people without diabetes.
Lilly medical affairs vice president Leonard Glass said: “We are proud to build on our long heritage of developing new insulins with the approval of Lyumjev, an important new treatment option to help control post-meal blood sugar levels.
“Keeping blood sugar in the target range following meals can be challenging for people living with diabetes, and the approval of Lyumjev underscores our commitment to meeting their needs.”
Lyumjev has already been approved for use in Japan and the European Union
The US regulatory approval of Lyumjev was supported by data from the Phase 3 randomised, active-controlled clinical studies PRONTO-T1D and PRONTO-T2D, which compared Lyumjev with Humalog (insulin lispro injection, 100 units/mL) in adults with type 1 and type 2 diabetes.
Both the clinical trials reached the primary endpoint of non-inferior A1C reduction from baseline compared to Humalog, when Lyumjev and Humalog were dosed at mealtime. Key endpoints include adjusted for multiple testing, including the comparisons of one- and two-hour postprandial glucose.
In Phase 3 clinical trials, Lyumjev has shown a superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog. Both Lyumjev and Humalog showed similar safety and tolerability profiles.
Regulatory agencies in several markets, including Japan and the European Union, have approved Lyumjev in March 2020, and the company intends to commercialise Lyumjev for adults with diabetes in the US.
Lilly US connected care and insulins vice president Adrienne Brown said: “Lilly is committed to ensuring all of our insulins, including Lyumjev, are accessible to people living with diabetes through our wide range of affordability options, such as the Lilly Insulin Value Program. We want people who use Lilly insulin and need help affording their medicine to know that we’re here to support them.”