Big Molecule Watch
June 18, 2020

FDA Approves LYUMJEV (insulin lispro-aabc injection)

This week, the FDA approved LYUMJEV (insulin lispro-aabc), a new insulin lispro product by Lilly. LYUMJEV is a formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C levels. Lilly’s insulin lispro product HUMALOG was originally approved in 1996.

The corresponding Lilly press release for LYUMJEV states: “The approval of Lyumjev 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® (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.”

Sanofi has a follow-on insulin lispro product, ADMELOG, which was approved by the FDA in December 2017.  ADMELOG was approved as a biosimilar in Europe in July 2017.

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