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Type 1

Ultra Rapid-Acting Insulin Approved for Children with Diabetes

Based on recently published clinical trial data, an ultra rapid-acting mealtime insulin was just approved for use in children with diabetes, expanding the mealtime insulin options available for children.

Insulin manufacturer Eli Lilly & Co. announced on Oct. 20 that its ultra rapid-acting mealtime insulin Lyumjev (insulin lispro-aabc) was approved by the FDA for children with type 1 diabetes. Lyumjev was first approved to lower glucose levels for adults with type 1 and type 2 diabetes in June 2020.

This expanded FDA approval comes from the PRONTO-Peds trial, a phase three study that included 716 children with type 1 diabetes aged 1 year and older, and from studies in other adults and children with diabetes. PRONTO-Peds compared the effects of Lyumjev versus Humalog on glucose levels when administered just before a meal or 20 minutes after starting the meal. The study found that Lyumjev was just as effective as Humalog at lowering glucose after meals in children with type 1 diabetes.

Lyumjev is available for adults in several markets, including the United States, the European Union (EU), and Japan. Though not yet approved for children in the EU, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended on Oct. 13 that Lyumjev be made available for children with diabetes aged 1 or older. It is anticipated that approval for children in Europe will quickly follow the committee’s recommendation.

Several rapid-acting mealtime insulins are currently available for adults and children with diabetes, including Novolog, Humalog, Apidra, and Admelog. These insulins generally work quickly (within 30 minutes) to lower glucose levels.

Ultra rapid-acting insulins, such as Fiasp, Lyumjev, and Afrezza (an inhalable insulin), can  lower glucose levels more quickly, within approximately 12-20 minutes. Of these three insulins, however, Lyumjev is currently the only approved option for children.

Because of its ultra rapid-acting effect, Lyumjev can be taken at the start of a meal or up to 20 minutes after starting the meal. However, it is still recommended that adults and children take Lyumjev before the start of the meal when possible.

For the estimated 283,000 children in America under the age of 19 with diabetes, keeping blood glucose levels in target range can be a significant challenge. Having an ultra-rapid acting insulin option available could help children with type 1 diabetes manage their glucose levels.

For more information about Lyumjev and other available insulin options, see:

FDA Approves Lyumjev – A New Rapid-Acting Mealtime Insulin

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