From the Journals

FDA approves first follow-on short-acting insulin product using abbreviated approval pathway


The Food and Drug Administration has approved Sanofi’s insulin lispro injections (Admelog) for improved blood sugar control in adults and children aged 3 years and older with type 1 and type 2 diabetes mellitus, according to a news release from the FDA.

Insulin lispro injections are to be administered subcutaneously by injection, infusion via an insulin pump, or intravenously. Doses should be individualized based on route of administration and patients’ individual metabolic needs. All diabetes patients should regularly monitor their blood sugar levels and insulin regimens should be exclusively modified under medical supervision.

“With today’s approval, we are providing an important short-acting insulin option for patients that meets our standards for safety and effectiveness,” Mary T. Thanh Hai, MD, deputy director of the Office of New Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, said in a statement.

Admelog, a biosimilar to Eli Lilly’s Humalog, was approved as a follow-on product based on the prior approval of Humalog. This allowed insulin lispro injections to be passed through the abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, formally known as the 505(b)(2) pathway. The makers of insulin lispro found it was scientifically justified to use the previous safety and effectiveness data from the approval of Humalog to support the approval of insulin lispro injections. In addition to the Humalog data, the insulin lispro injection data included findings from two phase 3 clinical trials, each of which comprised about 500 diabetes patients. Using this abbreviated pathway can reduce the costs of drug development significantly, allowing new products to be offered to patients at lower prices.

“One of my key policy efforts is increasing competition in the market for prescription drugs and helping facilitate the entry of lower-cost alternatives. 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,” FDA Commissioner Scott Gottlieb, MD, said in a statement “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.”

Insulin lispro injections are short-acting insulin products that can help improve blood sugar levels in diabetes patients. This can be useful in controlling blood sugar levels after eating. This contrasts with long-acting insulin products, which are intended to control background insulin levels between meals. The blood sugar control needs of type 1 and type 2 diabetes patients are unique. Type 1 patients require both short- and long-term controls, while some type 2 patients may never need a short-acting insulin product. Because of these differences, providing insulin lispro injections as a blood sugar control method may be particularly useful to type 1 diabetes patients who need to control mealtime blood sugar levels.

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