FDA Approves Short-Acting Follow-On Insulin

Yesterday, the FDA granted approval to Ademlog (insulin lispro injection). The short-acting insulin was found to improve blood glucose levels in patients 3 years and older

with type 1 diabetes (T1D) and adults with type 2 diabetes (T2D), according to a press release.

The FDA noted that Admelog was approved as a follow-on insulin through the 505(b)(2) pathway.

The CDC recently estimated that more than 30 million Americans have diabetes, which increases the risk of heart disease, blindness, nerve damage, organ damage, and other complications. Controlling glucose levels with insulin therapy can mitigate some of these complications, according to the FDA.

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives,” said FDA Commissioner Scott Gottlieb, MD. “This is particularly important for drugs like insulin that are taken by millions of Americans every day for a patient’s lifetime to manage a chronic disease.”

Admelog was approved under the abbreviated pathway, which relies on FDA evidence that a previously approved drug is safe and effective or through published literature that shows the safety and/or efficacy of the drug, according to the release.

Notably, the FDA said that the pathway can lower the cost of drug development, which may lead to lower costs for patients.

For Admelog, the 505(b)(2) application relied on the FDA’s safety and efficacy data for Humalog (insulin lispro injection). The manufacturer demonstrated the data for Humalog were justified. The manufacturer also provided safety and efficacy data for Admelog, including two phase 3 clinical trials that included 500 patients each, according to the release.

“In the coming months, we’ll be taking additional policy steps to help to make sure patients continue to benefit from improved access to lower cost, safe and effective alternatives to brand name drugs approved through the agency’s abbreviated pathways,” Dr Gottlieb said.

Admelog is a short-acting insulin that is typically administered at mealtimes to control blood glucose levels after eating, according to the FDA. Short-acting insulins can also be used in insulin pumps to meet background and mealtime insulin needs.

In contrast, long-acting insulins typically provide background insulin to control blood sugars between meals. Patients with T1D require both types of insulin, while patients with T2D may not require treatment with a short-acting insulin, the FDA reported.

“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 the FDA Center for Drug Evaluation and Research.

Admelog can be administered through an injection, a subcutaneous infusion, or an intravenous infusion. The FDA advises that dosing should be individualized based on administration and patient needs.

Common adverse events include hypoglycemia, itching, and rash. Other adverse events include allergic reactions, injection site reactions, and lipodystrophy.