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Lyumjev FDA Approval History

Last updated by Judith Stewart, BPharm on Sep 1, 2021.

FDA Approved: Yes (First approved June 15, 2020)
Brand name: Lyumjev
Generic name: insulin lispro-aabc
Dosage form: Injection
Company: Eli Lilly and Company
Treatment for: Diabetes, Type 1, Diabetes, Type 2

Lyumjev (insulin lispro-aabc) is a rapid-acting human insulin analog indicated to improve glycemic control in adults with diabetes mellitus.

  • Lyumjev (insulin lispro-aabc) is a novel formulation of insulin lispro, developed to speed the absorption of insulin into the blood stream and reduce A1C levels. 
  • Lyumjev 100 units/mL (U-100) injection is available as multiple-dose vials, and single-patient-use prefilled pens and cartridges. Lyumjev 200 units/mL (U-200) injection is available as single-patient-use prefilled pens.
  • Lyumjev U-100 and U-200 are administered subcutaneously into the abdomen, upper arm, thigh, or buttocks at the start of a meal, or within 20 minutes after starting a meal. Lyumjev U-100 can be administered by continuous subcutaneous infusion using an insulin pump, and intravenously under medical supervision. Lyumjev U-200 should not be administered by continuous subcutaneous infusion or intravenous infusion.
  • Common side effects include hypoglycemia, injection site reactions, allergic reactions, rash, pruritus, lipodystrophy, and weight gain.

Development timeline for Lyumjev

DateArticle
Aug 16, 2021Approval FDA Approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for Use in Insulin Pumps
Jun 15, 2020Approval FDA Approves Lyumjev (insulin lispro-aabc injection) for Type 1 and Type 2 Diabetes

Further information

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