Lilly’s diabetes drug rejected by FDA

NEW YORK — A diabetes pill developed by Eli Lilly and Co. and Boehringer Ingelheim Pharmaceuticals Inc. was rejected by US regulators because of previously disclosed manufacturing deficiencies that had not been resolved at a German plant.

The Food and Drug Administration inspected Boehringer’s Ingelheim am Rhein facility in 2012 and warned the Ingelheim-based company of the faults in May 2013. No new clinical studies will be needed to approve the drug, called empagliflozin, the companies said Wednesday in a statement.

The FDA won’t approved the drug until the problems are fixed.


About 24 million people in the United States have diabetes, a condition, often driven by obesity, in which the body loses its ability to process sugar.

Get Today's Headlines in your inbox:
The day's top stories delivered every morning.
Thank you for signing up! Sign up for more newsletters here

Empagliflozin is part of a class of drugs that includes Johnson & Johnson’s Invokana and AstraZeneca’s Forxiga. The drugs help the body get rid of sugar through the kidneys.

The Lilly-Boehringer drug is projected to garner $295 million in sales for Lilly in 2019, according to analyst estimates compiled by Bloomberg.

The FDA reinspection of Boehringer’s plant is continuing, said Emily Baier, a spokeswoman for the company. ‘‘The inspection is reviewing aspects related to production, processes, quality assurance, and other related areas,’’ she said in an e-mail.

It could take up to six months after the inspection for the FDA to decide whether the problems have been fixed.


The 2012 inspection found what the FDA called ‘‘significant violations of current manufacturing practice’’ at the plant. They included a failure to look into issues with the active ingredients of a drug made there as well as contamination problems that also were not investigated.

Bloomberg News