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FDA Approves Sanofi’s Admelog

This is the first follow-on mealtime insulin ever approved by the FDA

By: Betsy Louda

, Contract Pharma

The U.S. Food and Drug Administration has approved Sanofi‘s Admelog, which is 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 of Global Diabetes and Cardiovascular at Sanofi. 

 

Admelog is a rapid-acting insulin similar to Humalog, another insulin lispro 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. It 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.

 

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