FDA Issues Complete Response Letter on Adjunct Therapy for Patients With Type 1 Diabetes

The 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 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.

“The challenges of managing blood sugar levels for those with type 1 diabetes, and the desire for new treatment options, reveal important unmet needs in the diabetes community,” said Mohamed Eid, MD, MPH, MHA, vice president of Clinical Development & Medical Affairs at Boehringer Ingelheim Pharmaceuticals. “We remain committed to the continued study of therapies that may improve outcomes for adults with cardiorenal metabolic conditions, including diabetes.”

Reference

• US FDA issues complete response letter for empagliflozin 2.5 mg as adjunct to insulin for adults with type 1 diabetes [news release]. Ridgefield, CT and Indianapolis, IN. Published March 20, 2020. https://investor.lilly.com/news-releases/news-release-details/us-fda-issues-complete-response-letter-empagliflozin-25-mg. Accessed March 27, 2020.