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# Lilly BLA for Insulin Lispro Approved
- URL: https://www.fdaweb.com/lilly-bla-for-insulin-lispro-approved/
- Published: 2020-06-16T12:00:00.000Z
- Updated: 2026-09-14T16:18:20.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5147019

FDA has approved an Eli Lilly BLA for Lyumjev (insulin lispro-aabc) injection, 100 units/mL and 200 units/mL, a new rapid-acting insulin indicated to improve glycemic control in adults with Type 1 and Type 2 diabetes. The company says the novel formulation of insulin lispro was developed to speed the absorption of insulin into the blood stream and reduce A1C levels. “As a rapid-acting mealtime insulin, Lyumjev controls high blood sugar levels after meals in adults with diabetes, similar to how natural insulin works after meals in people without diabetes,” it says.

Approval was based on data from the Phase 3 studies PRONTO-T1D and PRONTO-T2D, which were randomized, active controlled, treat-to-target comparisons of Lyumjev and Humalog. Both studies met their primary endpoint of noninferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime, Lilly says. Key endpoints were adjusted for multiple testing, including the comparisons of one- and two-hour postprandial glucose. “In both studies, Lyumjev demonstrated superior reduction in blood glucose spikes at both one hour and two hours after a test meal compared to Humalog,” it says.