FDA Rejects Supplemental Application for Empagliflozin in Type 1 Diabetes Treatment
Eli Lilly
Global Pharmaceutical R&D and Production Company
FDA
U.S. Food and Drug Administration
On March 20, Eli Lilly announced that it had received a complete response letter from the FDA. The FDA rejected its supplemental application for approval of the SGLT2 inhibitor empagliflozin for the treatment of type 1 diabetes.
Empagliflozin, jointly developed by Eli Lilly and Boehringer Ingelheim, was approved by the FDA in August 2014 for the treatment of adult patients with type 2 diabetes. In December 2016, the FDA further approved empagliflozin for a new indication: reducing cardiovascular risk in patients with type 2 diabetes.
Type 1 diabetes is a chronic autoimmune disease that currently affects millions of people worldwide and is most common in children and adolescents. Also known as insulin-dependent diabetes mellitus, type 1 diabetes requires patients to inject insulin daily to survive.
*Disclaimer: This article was written by an author contributing to Sina Medical News. The views expressed are solely those of the author and do not represent the position of Sina Medical News.
