FDA Approves Rapid-Acting Insulin Injection

By Adam Hochron

The FDA has approved two doses of an insulin lispro-aabc injection (100units/mL and 200 units/mL) to improve glycemic control in adults with type 1 and type 2 diabetes. 

A press release from the manufacturer noted that the treatment is a novel formulation developed to speed up insulin absorption into the bloodstream, thereby reducing A1C levels. The treatment is approved for use during mealtime to help patients control their blood sugar levels, according to the release.

“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, of the Campbell University of Osteopathic Medicine in the release. “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.”

The approval follows the Phase 3 PRONTO-T1D and PRONTO-T2D studies, which compared Lyumjev and the insulin lispro injection (100 units/mL). The primary endpoint of non-inferior A1C reduction from baseline compared to the other treatment were met in both studies, according to the release. Other endpoints included comparing one-and two-hour postprandial glucose, with Lyumjev demonstrating superior reduction at both points. 

Lyumjev is not indicated for use during hypoglycemia or in patients with hypersensitivity to insulin lispro “or one of the excipients in Lyumjev,” the release noted. Hypoglycemia is the most common adverse reaction associated with Lyumjev and other insulins.  


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