Lilly's fast-acting insulin Lyumjev has been approved by the FDA

yesterday, Lilly announced that the FDA has approved its new type of meal-time insulin Lyumjev (insulin lispro-aabc, 100 units/mL and 200 units/mL) to improve blood sugar control in adult patients with type 1 and type 2 diabetes.Lyumjev is a new, quick-acting formula for insulin lispro, Humalog, designed to accelerate insulin absorption in the bloodstream and lower A1C levels. As a quick-acting form of insulin, Lyumjev controls high blood sugar levels after meals in diabetics, similar to the role of natural insulin in non-diabetic meals.It is reported that the approval of Lyumjev is based on phase 3 clinical studies PRONTO-T1D and PRONTO-T2D data. The two studies, conducted in adults with type 1 and type 2 diabetes, compared the efficacy and safety of Lyumjev and Humalog in combining insulin glycelin or deglu insulin, respectively. In both studies, each group received treatment until the same blood sugar control levels were reached to allow comparisons in other important therapeutic effects, such as low blood sugar rates, post-meal blood sugar control, and blood sugar time ranges.The results showed that both studies reached the primary endpoint: medication at meal time, and Lyumjev was not inferior to Humalog in terms of A1C relative baseline reduction during week 26 of treatment. In addition, the trial adjusted the main endpoint indicators for a number of tests, including a comparison of blood sugar 1 hour after meals and 2 hours after meals. In both studies, Lyumjev significantly reduced blood glucose peaks 1 hour after meals (-27.9mg/dL(T1D), -11.8mg/dL (T2D)) and 2 hours after meals (-31.2mg/dL (T1D), -17.4mg/dL (T2D). In the study, Lyumjev and Humalog had similar safety and tolerance.In March 2020, Lyumjev has been approved by regulators in several global markets, including Japan and the European Union. The Lilly announcement also noted that Lyumjev will be included in Lilly's insulin value program at the same price as Humalog. (Sina Pharmaceutical News)