FDA approves short-acting insulin Admelog for type 2 diabetes

The FDA on Monday announced the approval of Admelog, the first follow-on short-acting insulin indicated to improve blood glucose control in adult and pediatric patients with type 1 or type 2 diabetes, according to an agency press release.

The approval of follow-on insulin lispro (Admelog, Sanofi) was achieved through an abbreviated approval pathway under the Food, Drug and Cosmetic Act. 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.

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

In its abbreviated pathway application, Sanofi relied, in part, on the FDA’s finding of safety and effectiveness for insulin lispro injection (Humalog, Eli Lilly) to support approval. The applicant demonstrated that reliance on the FDA’s finding of safety and effectiveness for insulin lispro was scientifically justified and provided drug-specific data to establish the its safety and efficacy for its approved uses, according to the FDA. The follow-on insulin lispro-specific data included two phase 3 clinical trials that enrolled approximately 500 patients in each. The drug received tentative approval from the FDA in September.

“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 the release.

Follow-on insulin lispro can be administered by subcutaneous injection under the skin, subcutaneous infusion (ie, via insulin pump) or IV infusion. Dosing should be individualized based on the route of administration and the patient’s metabolic needs, blood glucose monitoring results and glycemic control goal.

The most common adverse reactions associated with follow-on insulin lispro in clinical trials was hypoglycemia, itching and rash. Other adverse reactions that can occur include allergic reactions, injection site reactions, and thickening or lipodystrophy.