The FDA's approval of insulin lispro-aabc injection is based on the results of 2 phase 3 trials—PRONTO-T1D and PRONTO-T2D.
Both type 1 and type 2 diabetics now have an additional insulin option available to them in the form of insulin lispro-aabc injection (Lyumjev) 100 units/mL and 200 units/mL, thanks to a recent approval from the US Food and Drug Administration (FDA).
Designed to increase the absorption speed of insulin into the bloodstream and reduce A1C levels, the new rapid-acting insulin received approval from the FDA for improving glycemic control in type 1 and type 2 diabetics, according to a statement released by Eli Lilly and Company.
"Thanks to advances in glucose monitoring, the people with diabetes I treat in my practice are able to more clearly see the blood glucose spikes that happen naturally after a meal," said Mark Warren, MD, assistant professor of medicine at Campbell University of Osteopathic Medicine, in the aforementioned statement. "With its fast onset, Lyumjev is a meaningful development for people who want their insulin to help manage their A1C and reduce those post-meal spikes."
Approval of insulin lispro-aabc injection is based on results from a pair of phase 3 studies, titled PRONTO-T1D and PRONTO-T2D, both of which were designed as randomized, active-controlled, treat-to-target comparisons of insulin lispro-aabc injection against insulin lisper injection 100 unit/mL (Humalog). The primary endpoint, which was noninferior for HbA1c reduction from baseline to 26 weeks when compared against the comparator using mealtime dosing, was achieved in both trials.
Additionally, the statement from Eli Lilly and Company noted insulin lispro-aabc injection was associated with superior reduction in blood glucose spikes both 1 hour and 2 hours after a meal compared against Humalog. Results of the phase 3 studies also indicated insulin lispro-aabc injection had a similar safety and tolerability profile to Humalog.
Eli Lilly and Company also noted plans to include insulin lispro-aabc injection in the Lilly Insulin Value Program, which allows anyone with commercial insurance and those without insurance to fill a monthly prescription for $35. The statement also noted Eli Lilly and Company is working to make insulin lispro-aabc injection available to adults with diabetes in the US as quickly as possible.
Prescribing information for insulin lispro-aabc injection warns against use during episodes of hypoglycemia and in those who are hypersensitive to insulin lispro-aabc or one of the excipients in insulin lispro-aabc injection. The prescribing info also highlights hypoglycemia, injection site reactions, allergic reactions, rash, pruritus, lipodystrophy, and weight gain were all adverse reactions seen with insulin lispro-aabc injection.