FDA Approves Lyumjev for Use with Insulin Pump

The FDA has approved an expanded label for Eli Lilly’s rapid-acting insulin, Lyumjev (insulin lispro-aabc) to include administration via an insulin pump.

“Insulin pumps are an important delivery option for people with diabetes – many of whom struggle with high postmeal blood sugar levels,” Leonard Glass M.D., vice president of medical affairs, Lilly, said in a statement. "The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes.”

The approval was based on results from PRONTO-PUMP-2, a phase 3 study that confirmed the efficacy and safety of Lyumjev when used in insulin pumps in adults with type 1 diabetes. The study met the primary end point of noninferior A1C reduction from baseline to week 16 compared with Lilly’s Humalog (insulin lispro). Lyumjev demonstrated superior reduction in blood glucose spikes at both one and two hours after a test meal compared with Humalog.

The injection formulation of Lyumjev, a novel insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce A1C levels, was approved by the FDA in June 2020. This approval was based the phase 3 studies PRONTO-T1D and PRONTO-T2D, which were randomized, active controlled, treat-to-target comparisons of Lyumjev and Humalog in adults with type 1 and type 2 diabetes. Both studies met the primary end point of noninferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime

Lyumjev comes in two strengths: U-100 (100 units per milliliter) and U-200 (200 units per milliliter).