Posted by Michael Wonder on 20 Mar 2020
US FDA issues complete response letter for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes
20 March 2020 - The U.S. FDA has issued a complete response letter for the supplemental new drug application of the investigational medicine empagliflozin 2.5 mg as an adjunct to insulin for adults with type 1 diabetes.
Empagliflozin 2.5 mg is being developed by Boehringer Ingelheim and Eli Lilly.
The letter indicates that the FDA is unable to approve the application in its current form, consistent with the outcome of the Endocrinologic and Metabolic Drugs Advisory Committee in November.
