Drugmakers Eli Lilly and Boehringer-Ingelheim said Tuesday that the Food and Drug Administration didn’t approve their diabetes treatment empagliflozin because of concerns about a facility where the drug will be made.
The companies said the FDA isn’t asking for new studies of empagliflozin. They said they intend to reply to the agency as soon as possible.
Empagliflozin is a tablet that is intended to be taken once per day as a treatment for type 2 diabetes. It is designed to reduce a patient’s blood sugar levels by blocking glucose reabsorption in the kidneys and removing excess glucose through urine. Unlike other diabetes treatments, it does not depend on a patient’s insulin levels to be effective.
The drug will be made at a facility in Ingelheim, Germany. In May, the FDA sent Boehringer-Ingelheim a warning letter that cited “significant violations” of manufacturing standards at the facility. The agency said the company failed to investigate and fix foreign particles that were found in an active drug ingredient that was being manufactured, among other concerns. The problems date to a 2012 inspection of the facility, as the FDA says Boehringer-Ingelheim hasn’t corrected problems that were found during that inspection.
Boehringer-Ingelheim says the warning was related to commercial drug production and not to empagliflozin.
Eli Lilly, of Indianapolis, and Boehringer-Ingelheim started teaming up in 2011 to design and sell several diabetes treatments.