First “Follow-On” Insulin Product Approved

FDA green lights Admelog to treat both type 1 and 2 diabetes.

The FDA announced it has approved a short-acting insulin able to improve the control of blood sugar levels in adults and children aged 3 years and older with type 1 diabetes mellitus and adults with type 2 diabetes mellitus. Known as Admelog, the approved insulin was approved as a “follow-on” product, which regulators explained is submitted through the agency’s 505(b)(2) pathway.

Granted tentative approval to Sanofi-Aventis September 1, 2017, Admelog is now being granted final approval. CDC data shows more than 30 million people in the U.S. have diabetes. A chronic disease, diabetes can produce severe negative health effects over time if not treated effectively and it is well known by caregivers and patients that the better one controls their blood sugar, the less risk there is suffering from long-term complications.

Projecting the agency’s agenda, FDA Commissioner Scott Gottlieb, noted: “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.”

In the coming months, explained Gottlieb, the FDA will be further changing policy to help assure patients benefit from better access to lower-cost, safe, effective alternatives. Identified as a “short-acting” insulin product, Admelog is effective when administered before meals to control blood glucose levels. According to FDA, these types of insulins can be used in pumps and similar automated drug delivery devices to meet patients’ maintenance and meal time dosing needs.

In contrast, long-acting insulin products including insulin glargine, insulin degludec and insulin detemir, (all generally administered to deliver background level of insulin to control blood sugars between meals, and administered at least twice a day). While both long- and short-acting insulins can play an important role in treating types 1 and 2 diabetes mellitus, patients with type 1 diabetes, explained FDA, require both types of insulin while patients with type 2 diabetes may never need a short-acting insulin product. “With today’s approval, we are providing an important short-acting insulin option for patients that meets our standards for safety and effectiveness,” said Deputy Director Mary T. Thanh Hai of the Office of New Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research.


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