FDA issues Complete Response Letter to Eli Lilly and Boehringer for empagliflozin to treat type 1 diabetes.

The FDA has issued a complete response letter for the supplemental New Drug Application (sNDA) 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 and Company .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 2019.