The US Food and Drug Administration (FDA) has approved the short-acting “follow-on” insulin Admelog® (insulin lispro injection) 100 Units/mL for children age 3 and older with type 1 diabetes and adults with type 2 diabetes.
This final approval follows tentative drug approval granted to Sanofi-Aventis on September 1, 2017.
“With today’s approval, we are providing an important short-acting insulin option for patients that meets our standards for safety and effectiveness,” said Mary T. Thanh Hai, MD, deputy director of the Office of New Drug Evaluation II, in an FDA press release.
Approval was granted via an abbreviated 505(b)(2) approval pathway, which relies on previous FDA findings regarding the drug’s safety and efficacy. Admelog approval was based in part on the safety and efficacy findings for Humalog, including 2 phase 3 clinical trials of more than 1000 adults with type 1 or type 2 diabetes.
Admelog may be administered through subcutaneous injection or intravenous infusion. Dosing should be based on individual patient needs. The most common adverse reactions associated with Admelog include hypoglycemia, itching, and rash.
FDA approves Admelog, the first short-acting “follow-on” insulin product to treat diabetes [news release]. Silver Spring, MD: US Food and Drug Administration. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588466.htm. Published December 11, 2017. Accessed December 11, 2017.