Lyumjev FDA Approval History
Last updated by Judith Stewart, BPharm on Oct 31, 2022.
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, Type 2 Diabetes
Lyumjev (insulin lispro-aabc) is a rapid-acting human insulin analog indicated to improve glycemic control in adult and pediatric patients 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
| Date | Article |
|---|---|
| Oct 14, 2022 | Approval Lyumjev (insulin lispro-aabc) Injection Approved by U.S. FDA for Children with Diabetes |
| Aug 16, 2021 | Approval FDA Approves Lyumjev (insulin lispro-aabc injection) 100 units/mL for Use in Insulin Pumps |
| Jun 15, 2020 | Approval FDA Approves Lyumjev (insulin lispro-aabc injection) for Type 1 and Type 2 Diabetes |
Further information
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