FDA Gives Final OK to First Short-Acting Follow-On Insulin for Diabetes

Officials with the FDA today approved insulin lispro injection (Admelog, Sanofi-Aventis US) 100 units/mL, the first short-acting insulin approved as a follow-on product. The final approval follows tentative approval, which was granted on September 1, 2017.

Insulin lispro injection is indicated to improve control in blood sugar levels in adults and children aged 3 years and older with type 1 diabetes and adults with type 2 diabetes.

Since the drug’s application was submitted through an abbreviated approval pathway, called the 505(b)(2) pathway, Admelog’s approval was supported by the FDA’s finding of safety and effectiveness for Humalog, another insulin lispro, according to an FDA press release. The applicant demonstrated that reliance on the FDA’s findings for Humalog was scientifically justified and provided Admelog-specific data to establish the drug’s safety and efficacy for its approved uses. This data included two phase 2 clinical trials that enrolled 500 patients in each.

Short-acting insulins are typically administered before meals to control blood sugar levels after eating, and can be used in insulin pumps to meet both background insulin needs and mealtime insulin needs. Although patients with type 2 diabetes may never need a short-acting insulin product, many with type 1 diabetes require both types of insulin.

Insulin lispro injection can be administered by injection under the skin, subcutaneous infusion, or intravenous infusion. Dosing should be individualized based on the route of administration and the patient’s metabolic needs, blood glucose monitoring results, and glycemic control goal.

The most common adverse events associated with insulin lispro injection in clinical trials was hypoglycemia, itching, and rash.

The FDA urges patients or caregivers to monitor blood glucose in all patients treated with insulin products, and to check insulin labels before injecting the product to prevent accidental mix-ups between insulin products. Patients should be monitored more closely with changes to insulin dosage, co-administration of other glucose-lowering medications, meal pattern, physical activity, and in patients with renal impairment or hepatic impairment or hypoglycemia unawareness.

References

FDA approves Admelog, the first short-acting "follow-on" insulin product to treat diabetes [news release]. FDA’s website. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588466.htm?utm_campaign=12112017_FDA%20approves%20Admelog&utm_medium=email&utm_source=Eloqua. Accessed December 11, 2017.