FDA Approves Rapid-Acting Insulin, Lyumjev, for Pump Use

Miriam E. Tucker

Disclosures

August 17, 2021

The US Food and Drug Administration (FDA) has expanded the label for Eli Lilly's ultra-rapid-acting insulin lispro-aabc injection 100 units/mL (Lyumjev) for use in insulin pumps.

Lyumjev (insulin lispro-aabc injection 100 and 200 units/mL) was initially approved in June 2020 to improve glycemic control in adults with type 1 or type 2 diabetes. That formulation is administered by injection from a pen or syringe. Now, the 100 units/mL formulation can also be delivered via continuous subcutaneous insulin infusion with an insulin pump.

Lyumjev will compete with Novo Nordisk's fast-acting insulin aspart injection 100 units/mL (Fiasp). Fiasp had a head start: it was approved for use in adults in the United States in September 2017. It was approved for use in insulin pumps in October 2019 and for use in children with diabetes in January 2020.

The new approval for Lyumjev was based on data from a phase 3 trial, PRONTO-Pump-2. That trial, which included 432 participants with type 1 diabetes, confirmed the drug's safety and efficacy when used in pumps.

The study met the primary endpoint of noninferiority in reduction of A1c from baseline to week 16 compared to insulin lispro (Humalog 100 units/mL). It was superior in both 1-hour and 2-hour postprandial glucose reduction when delivered 0–2 min before meals, according to a Lilly statement.

Patients who cannot afford the drug can go to www.insulinaffordability.com for assistance. Those with commercial insurance can also visit www.Lyumjev.com to access the Lyumjev Savings Card.

Lyumjev is available in several global markets, including Japan and the European Union, where it is also approved for use in insulin pumps.

Miriam E. Tucker is a freelance journalist based in the Washington, DC, area. She is a regular contributor to Medscape. Other work of hers has appeared in the Washington Post, NPR's Shots blog, and Diabetes Forecast magazine. She can be found on Twitter @MiriamETucker.

For more diabetes and endocrinology news, follow us on Twitter and Facebook.

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....