Lyumjev, a New Formulation of Insulin Lispro, Receives Approval

June 15, 2020 – The U.S. FDA has approved Eli Lilly’s Lyumjev^TM (insulin lispro-aabc injection), a new rapid-acting human insulin analog, to improve glycemic control in adults who have diabetes mellitus.

More than 32 million people in the United States have diabetes, a disease that occurs when the body can’t properly use the insulin it makes and/or can’t make enough insulin on its own. This leads to high blood sugar (poor glycemic control), which can be dangerous. Poor glycemic control increases the risk of serious diabetes complications such as kidney and nerve damage, cardiovascular disease, damage to the eyes and feet, hearing impairment, depression, and dementia. Lyumjev is a new formulation of insulin lispro designed for rapid absorption into the body that can help certain patients with diabetes manage their blood sugar levels.

In clinical studies, Lyumjev achieved superior reduction in blood glucose spikes at both one hour and two hours after a meal compared to Eli Lilly’s Humalog® (insulin lispro injection, 100 units/mL), a similar drug that received FDA approval in 1996. Lyumjev was also found to be noninferior at reducing A1C (a test used to measure a patient’s average blood glucose level) with mealtime dosing when compared to Humalog.

Recommended dosing for Lyumjev is based on the individual patient’s metabolic needs, glucose monitoring results, and glycemic control goals. Dose adjustments may be needed when switching from another insulin, with changes in physical activity, changes in concomitant medications, changes in meal patterns, changes in renal or hepatic function, or during acute illness. Lyumjev can be administered either as a subcutaneous injection or an intravenous infusion. Unlike Humalog, it is not FDA-approved for use with an insulin pump for continuous subcutaneous infusion. Lyumjev is a mealtime insulin and should generally be used in conjunction with an intermediate or long-acting insulin. It should be administered at the start of a meal or within 20 minutes after starting a meal.

Eli Lilly has launched Lyumjev at a wholesale acquisition cost (WAC) of $530.40 per box of five KwikPens®, which is comparable to the WAC for Humalog per equivalent dosage form.