FDA approves Lyumjev (insulin lispro-aabc injection), a new rapid-acting insulin.- Eli Lilly

The FDA has approved Lyumjev (insulin lispro-aabc injection, 100 units/mL and 200 units/mL), Eli Lilly and Company's new rapid-acting insulin indicated to improve glycemic control in adults with type 1 and type 2 diabetes. Lyumjev is a novel formulation of insulin lispro, 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. The approval of Lyumjev was based on data from the Phase III studies PRONTO-T1D and PRONTO-T2D, which were randomized, active controlled, treat-to-target comparisons of Lyumjev and Humalog (insulin lispro injection, 100 units/mL) in adults with type 1 and type 2 diabetes, respectively. Both studies met the primary endpoint of noninferior A1C reduction from baseline compared to Humalog at 26 weeks, when Lyumjev and Humalog were dosed at mealtime. 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. In Phase III studies, Lyumjev and Humalog had similar safety and tolerability profiles. Lyumjev is contraindicated during episodes of hypoglycemia and in patients with hypersensitivity to insulin lispro or one of the excipients in Lyumjev. Hypoglycemia, which can be serious and life-threatening, is the most common adverse reaction associated with insulins, including Lyumjev. Comment: This drug is approved in the EU under the name Liumjev .