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Eli Lilly and Company announced the FDA has expanded the label of insulin lispro-aabc injection (Lyumjev) to allow for administration via insulin pumps.
The US Food and Drug Administration has expanded the label for insulin lispro-aabc injection (Lyumjev) 100 unit/mL, according to a release from Eli Lilly and Company.
Announced in the August 16 release, the FDA’s expanded label approval allows for use of the novel formulation of insulin lispro to be administered via continuous subcutaneous insulin infusion with an insulin pump.
"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 aforementioned statement. "The expansion of the Lyumjev label to include use in an insulin pump provides a new and important choice for people with diabetes. It is an exciting development for pump users seeking to manage their blood sugar levels and reduce postmeal spikes."
With original approval dating back to June 2020, the latest label expansion for insulin lispro-aabc is based on the results of the PRONTO-PUMP-2 trial, according to Eli Lilly and Company. PRONTO-PUMP-2 was a phase 3 trial with a treat-to-target designed aimed at assessing the efficacy and safety of insulin lispro-aabc when used in insulin pumps 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 injection against insulin lispro injection (Humalog). The trial had a primary endpoint of noninferiority of insulin lispro-aabc injection to insulin lispro injection on change in HbA1c from baseline to week 16. According to the release from Eli Lilly and Company, the trial met its primary endpoint and demonstrated insulin lispro-aabc injection was associated with superior reductions in blood glucose spikes at both 1 and 2 hours after a test meal compared to insulin lispro injection.
According to Eli Lilly and Company, insulin lispro-aabc injection has already been approved for use in insulin pumps in Japan and the European Union. The company urges patients with diabetes to seek guidance from their healthcare providers and refer to the insulin pump maker instructions to see if insulin lispro-aabc injection can be used with their pump.