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FDA re-evaluating manufacturing process of diabetes pill as it considers approving drug

A diabetes pill developed by Eli Lilly and Boehringer Ingelheim was rejected by U.S. regulators because of previously disclosed manufacturing deficiencies at a German plant that had not been resolved.

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

“The complete response letter referenced previously observed deficiencies at a Boehringer Ingelheim facility where empagliflozin will be manufactured,” the companies said. The FDA will not approve 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.

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 reach sales of $295 million for Lilly in 2019, according to analyst estimates compiled by Bloomberg News.

The FDA re-inspection 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 rectified.

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 drugs made there as well as contamination problems that weren’t investigated.

The warning letter didn’t mention empagliflozin, Philip Johnson, Lilly’s vice president of investor relations, said on a Jan. 7 conference call.

“Empagliflozin was not specifically cited in that warning letter,” Johnson said. “There was other commercial production that was specifically referenced. Boehringer Ingelheim has been working through this with the FDA.”

— Bloomberg News

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