FDA Grants Insulin Lispro-aabc Label Expansion for use in Insulin Pumps

The novel prandial insulin formulation insulin lispro-aabc injection 100 U/ml (Lyumjev) this week received FDA approval for continuous subcutaneous administration with an insulin pump, according to a press statement from manufacturer Eli Lilly and Company.

"Insulin pumps are an important delivery option for people with diabetes – many of whom struggle with high postmeal blood sugar levels," said Leonard Glass MD, vice president of Medical Affairs with Eli Lilly and Company, in the company statement. "The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes.”

A more rapidly absorbed formulation, insulin lispro-aabc injection was approved in June 2020. The current label expansion is based on results of the PRONTO-PUMP-2 trial. PRONTO-PUMP-2 was a phase 3 active-controlled treat-to-target study to evaluate the safety and efficacy of insulin lispro-aabc injection when administered via insulin pump in adult patients with type 1 diabetes.

The 16-week trial enrolled 432 patients and randomized them in a 1:1 ratio to insulin lispro-aabc or insulin lispro (Humalog), each to be delivered as a bolus dose 0 to 2 minutes before meals. The study’s primary endpoint was noninferiority of insulin lispro-aabc to insulin lispro on change in A1c from baseline to week 16. The trial met its primary noninferiority endpoint, according to the company press statement, and insulin lispro-aabc also was associated with superior reduction in post-prandial blood glucose spikes at 1 and 2 hours after a test meal compared to insulin lispro.

Insulin lispro-aabc injection has already been approved for use in insulin pumps in Japan and the European Union. Patients with type 1 diabetes should discuss potential use of insulin lispro-aabc with their health care provider and refer to instructions from the manufacturer to see if insulin lispro-aabc injection can be used with their current insulin pump.