In mid-December, the U.S. Food and Drug Administration announced it had approved Sanofi-Aventis US’s (Bridgewater Township, NJ) Admelog (insulin lispro injection), a short-acting insulin indicated to improve control of blood glucose levels in adults and pediatric patients 3 years and older with type 1 diabetes and adults with type 2 diabetes. Admelog is the first short-acting insulin approved as a “follow-on” product [submitted through the agency’s 505(b)(2) pathway, a shortened route based on comparative evidence with an approved drug].
“With [the] 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’s Center for Drug Evaluation and Research.
Patients taking the drug should be monitored more closely with regard to changes in insulin dosage, co-administration of other glucose-lowering medications, meal pattern, and physical activity, as well as in patients with renal impairment, hepatic impairment, or hypoglycemia unawareness, the FDA noted.
Sanofi-Aventis submitted a 505(b)(2) application that relied, in part, on the FDA’s finding of safety and effectiveness for Eli Lilly’s Humalog (insulin lispro injection) to support approval for Admelog. The application aimed to demonstrate scientific justification for reliance on the FDA’s finding of safety and effectiveness for the reference product Humalog and provided Admelog-specific data from two Phase 3 trials.
“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. “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.”
He noted that these efforts are “particularly important for drugs like insulin that are taken by millions of Americans every day for a lifetime to manage a chronic disease.”
