Eli Lilly’s Lyumjev receives FDA approval

Eli Lilly has received FDA approval and expanded labelling for its Lyumjev rapid-acting insulin.

Lyumjev is a novel formulation of insulin lispro for speeding up insulin absorption into the bloodstream and reducing HbA1C levels over time. Lilly says the insulin could help control blood glucose levels after meals in adults with diabetes, similar to how natural insulin works in those without diabetes.

FDA approval in June 2020 came on the back of results from the Pronto-Pump-2 phase 3 trial that demonstrated efficacy and safety for Lyumjev when used in insulin pumps in adults with type 1 diabetes. The study met the primary endpoint of non-inferior A1C reduction from baseline to week 16 compared to Lilly’s Humalog insulin while also demonstrating a superior reduction in blood glucose spikes at one and two hours after a test meal, again compared to Humalog.

“Insulin pumps are an important delivery option for people with diabetes — many of whom struggle with high post-meal blood sugar levels,” Lilly VP of medical affairs Dr Leonard Glass said in a news release. “The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes.”

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