FDA Approves Lilly's Rapid-Acting Mealtime Insulin Lyumjev (insulin lispro-aabc) for Adults with Type 1 and Type 2 Diabetes

Today (June 16), Eli Lilly announced that the U.S. FDA has approved its new mealtime insulin, Lyumjev (insulin lispro-aabc, 100 units/mL and 200 units/mL), to improve glycemic control in adult patients with type 1 and type 2 diabetes.

Lyumjev is a novel, rapid-acting formulation of insulin lispro (Humalog), designed to accelerate insulin absorption into the bloodstream and lower A1C levels. As a rapid-acting mealtime insulin, Lyumjev controls postprandial hyperglycemia in patients with diabetes, mimicking the action of endogenous insulin in non-diabetic individuals after meals.

It is reported that the approval of Lyumjev was based on data from the Phase 3 clinical studies PRONTO-T1D and PRONTO-T2D. These two studies were conducted in adult patients with type 1 diabetes and type 2 diabetes, respectively, comparing the efficacy and safety of Lyumjev versus Humalog, each combined with either insulin glargine or insulin degludec. In both studies, patients in each group received treatment until they achieved the same level of glycemic control, to allow for comparisons in other important therapeutic outcomes, such as hypoglycemia rates, postprandial glucose control, and time in range.

The results showed that both studies met their primary endpoints: when administered at mealtimes, Lyumjev was non-inferior to Humalog in reducing A1C from baseline at Week 26. Furthermore, the primary endpoint analyses were adjusted for multiple testing, including comparisons of 1-hour and 2-hour postprandial glucose levels. In both studies, Lyumjev significantly reduced peak postprandial glucose levels at 1 hour (−27.9 mg/dL [T1D], −11.8 mg/dL [T2D]) and 2 hours (−31.2 mg/dL [T1D], −17.4 mg/dL [T2D]) compared with Humalog. Lyumjev and Humalog demonstrated similar safety and tolerability profiles in the studies.

In March 2020, Lyumjev received regulatory approval in multiple global markets, including Japan and the European Union. Eli Lilly also announced that Lyumjev would be included in the Eli Lilly Insulin Value Program, with pricing identical to that of Humalog.

Reference Source: FDA approves Lyumjev™ (insulin lispro-aabc injection), Lilly's new rapid-acting insulinhttps://investor.lilly.com/news-releases/news-release-details/fda-approves-lyumjevtm-insulin-lispro-aabc-injection-lillys-new