FDA Approves Rapid-acting insulin lispro-aabc Injection for Pump Therapy

Previously Published on Healio.com – The FDA approved an expanded label for rapid-acting insulin lispro-aabc injection to include administration via continuous subcutaneous infusion with an insulin pump, according to an industry press release.

As Healio previously reported, insulin lispro-aabc injection (Lyumjev, Eli Lilly), a novel formulation of insulin lispro developed to speed the absorption of insulin into the bloodstream and reduce HbA1c, was approved in June 2020 to improve glycemic response in adults with type 1 and type 2 diabetes.

Insulin Pump Therapy Provides an Important Choice for People with Diabetes

“Insulin pumps are an important delivery option for people with diabetes — many of whom struggle with high post-meal blood sugar levels,” Leonard Glass, MD, FACE, vice president of medical affairs at Lilly, said in the release. “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 post-meal spikes.”

The approval was based on results from PRONTO-Pump-2, a phase 3 treat-to-target study that confirmed the efficacy and safety of insulin lispro-aabc when used in insulin pumps by adults with type 1 diabetes. The study met the primary endpoint of noninferior HbA1c reduction from baseline to week 16 compared with insulin lispro recombinant (Humalog, Lilly). Insulin lispro-aabc demonstrated superior reduction in blood glucose spikes at both 1 and 2 hours after a test meal compared with insulin lispro recombinant.

Insulin lispro-aabc is available in the U.S. and in several global markets, including Japan and the European Union, where it is also approved for use in insulin pumps.

In the release, Lilly stated that people with diabetes should seek guidance from their health care providers and refer to the insulin pump manufacturer instructions to see whether insulin lispro-aabc 100 U/mL can be used with their pump.

Previously Published on Healio.com


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