FDA Approves Admelog, First Short-Acting “Follow-On” Insulin Product

Manufacturer used FDA’s 505(b)(2) abbreviated approval pathway

The FDA has approved Admelog (insulin lispro injection, Sanofi-Aventis U.S.), a short-acting insulin indicated to improve control in blood sugar levels in adults and pediatric patients ages 3 years and older with type-1 diabetes mellitus and adults with type-2 diabetes mellitus. Admelog is the first short-acting insulin approved as a “follow-on” product (submitted through the agency’s 505[b][2] pathway).

“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,” said FDA Commissioner Scott Gottlieb, MD. “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.”

Admelog was approved through an abbreviated approval pathway under the Federal Food, Drug, and Cosmetic Act, called the 505(b)(2) pathway. A new drug application submitted through this pathway may rely on the FDA’s finding that a previously approved drug is safe and effective or on published literature to support the safety and/or effectiveness of the proposed product, if such reliance is scientifically justified.

The use of abbreviated pathways can reduce drug development costs so products can be offered at a lower price to patients. In the case of Admelog, the manufacturer submitted a 505(b)(2) application that relied, in part, on the FDA’s finding of safety and effectiveness for Humalog (insulin lispro injection, Eli Lilly and Co.) to support approval. The applicant demonstrated that reliance on the FDA’s finding of safety and effectiveness for Humalog was scientifically justified and provided Admelog-specific data to establish the drug’s safety and efficacy for its approved uses. The Admelog-specific data included two phase 3 clinical trials that enrolled approximately 500 patients apiece.

Admelog is a short-acting insulin product, which can be used to help patients with diabetes control their blood sugar. Short-acting insulin products are generally, but not always, administered just before meals to help control blood sugar levels after eating. These types of insulin products can also be used in insulin pumps to meet both background insulin needs as well as mealtime insulin needs.

In contrast, long-acting insulin products, like insulin glargine, insulin degludec, and insulin detemir, are generally used to provide a background level of insulin to control blood sugars between meals, and are administered once or twice a day. While both types of insulin products can play important roles in the treatment of both type-1 and type-2 diabetes mellitus, patients with type-1 diabetes require both types of insulin while patients with type-2 diabetes may never need a short-acting insulin product.

Admelog received tentative approval from the FDA on September 1, 2017, and has now been granted final approval.

Source: FDA; December 11, 2017.