FDA approves Sanofi's Admelog

The U.S. Food and Drug Administration (FDA) has approved Sanofi's Admelog, the first follow-on insulin lispro to help people living with diabetes manage blood sugar levels at mealtime.

"Sanofi has a deep heritage and broad experience in providing treatments for people living with diabetes. 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."

Admelog is a rapid-acting insulin similar to Humalog, another insulin lispro 100 Units/mL, currently approved in the U.S. The Admelog clinical development program involved more than 1,000 adults living with type 1 or type 2 diabetes. Admelog will be available in both vials and the SoloStar pen, which is the most-used disposable insulin pen platform in the U.S.

Admelog was also granted marketing authorization as a biosimilar, under the proprietary name, Insulin lispro Sanofi, by the European Commission in July 2017.