Lyumjev Gets FDA Approval for Use in Insulin Pumps

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Lyumjev Gets FDA Approval for Use in Insulin Pumps

The U.S. Food and Drug Administration (FDA) has approved Eli Lilly’s insulin Lyumjev (insulin lispro-aabc) for use in insulin pumps, adding to its previous approval for multiple daily injections of the drug, as announced by the company in a press release.

Lyumjev was first approved by the FDA in June 2020, and is a new formulation of insulin lispro. The previous formulation of insulin lispro, sold under the brand name Humalog, was first approved by the FDA in 1996. Lyumjev was developed to help speed the absorption of insulin into the bloodstream, and has previously been used mainly as a mealtime insulin. Lyumjev is now approved for either multiple daily injections, or subcutaneous infusion using an insulin pump, for both type 1 and type 2 diabetes. It is available only by prescription in the United States.

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“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 at Eli Lilly, in the press 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 postmeal spikes.”

The latest approval was based on a study called PRONTO-PUMP-2, which looked at the safety and efficacy of Lyumjev when used in insulin pumps to treat type 1 diabetes. The main endpoint of that study was “noninferior” reduction of participants’ A1C (a measure of long-term blood glucose control) after 16 weeks, compared with Humalog. In fact, the study showed that Lyumjev was more effective at reducing blood glucose levels both one hour and two hours after a meal, compared with Humalog.

Lyumjev is already approved for use in insulin pumps in both the European Union and Japan, and is sold in many different countries around the world. It is not approved for use with any particular insulin pump, and pump users should refer to their pump’s instructions or other guidance from the manufacturer to find out if Lyumjev is compatible with their particular pump.

Talk to your doctor if you are interested in switching to a different type of insulin with your pump, as this process typically involves making adjustments to how you use your pump to deliver insulin. It’s important to follow your doctor’s instructions for this process, as your body may react differently to different types of insulin — potentially resulting in hypoglycemia (low blood glucose) or hyperglycemia (high blood glucose).

Want to learn more about insulin? Read “What Does Insulin Do?,” “Insulin: What You Need to Know” and “Insulin Basics.”

Quinn Phillips

Quinn Phillips

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A freelance health writer and editor based in Wisconsin, Phillips has a degree from Harvard University. He is a former Editorial Assistant for Diabetes Self-Management and has years of experience covering diabetes and related health conditions. Phillips writes on a variety of topics, but is especially interested in the intersection of health and public policy.

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