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Sanofi’s Insulin Add-On Approved by FDA

The drug is the first of its kind to be approved via the FDA’s abbreviated 505(b)(2) pathway, which uses previously-submitted safety and efficacy data for a comparable product to support approval.

Sanofi’s Insulin Add-On Approved by FDA

By: Sarah Hand, M.Sc.

Posted on: in News | Pharmaceutical News

The US Food and Drug Administration (FDA) has approved Sanofi’s short-acting insulin, Admelog (insulin lispro injection), designed to help pediatric and adult patients control their blood sugar levels at mealtime. The drug is the first of its kind to be approved via the FDA’s abbreviated 505(b)(2) pathway, which uses previously-submitted safety and efficacy data for a comparable product to support approval.

“Complementing our existing insulin portfolio, Admelog will offer a more affordable option for those who require control of their blood sugar levels at mealtime,” said Stefan Oelrich, Executive Vice President and Head, Global Diabetes and Cardiovascular, Sanofi. “The approval of Admelog is an important milestone for Sanofi in our mission to serve patients living with chronic diseases such as diabetes.”

According to the FDA, this accelerated pathway is designed to help speed the approval process thereby lowering the prescription drug costs for consumers. While Sanofi submitted Admelog-specific data from two Phase III clinical trials to the regulator, the approval relied heavily upon data for the company’s other insulin product Humalog.

“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 Dr. Scott Gottlieb. “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.”

Unlike long-acting insulin products which are administered just once or twice per day, short-acting products like Admelog are designed to be injected just before meals, or through an insulin pump for background blood sugar control. Sanofi plans to make Admelog available in both vials and their popular disposable insulin pen, SoloStar.

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

Over 30 million people in the US have diabetes, according to the Centers for Disease Control and Prevention (CDC). If the chronic disease is poorly-managed, patients run a higher risk of suffering complications, including nerve damage, kidney disease and loss of vision.


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