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Boehringer fixes factory, clearing way for new approval request
June 3, 2014 / 9:53 AM / in 4 years

Boehringer fixes factory, clearing way for new approval request

FRANKFURT, June 3 (Reuters) - Eli Lilly’s partner in a diabetes alliance, Boehringer Ingelheim, said that U.S. regulators had given it the go-ahead for a German plant after solving quality problems, paving the way for a renewed request for approval of a drug.

The U.S. Food and Drug Administration in March declined to approve Lilly and Boehringer’s experimental diabetes drug empagliflozin, citing manufacturing problems at Boehringer’s headquarters, where it would be made.

Boehringer on Tuesday said it was told by the FDA that based on a March inspection, the facility’s quality management and compliance systems were found to be acceptable again.

“This gives us the opportunity to renew our request for approval,” a company spokesman said.

The drug is a member of a new class of diabetes medicines known as SGLT2 inhibitors, which block the kidney from reabsorbing blood sugar, thereby spurring removal of glucose through the urine. Recently approved similar medicines include Johnson & Johnson’s Invokana.

Analysts surveyed by Thomson Reuters Cortellis on average expect Lilly to generate sales of more than $400 million from the drug in 2019.

The FDA issued a warning letter in May 2013 citing problems it found at the Boehringer plant during an inspection six months earlier. Among other issues, the FDA said it detected foreign particles in batches of active pharmaceutical ingredients.

Reporting by Ludwig Burger, editing by Louise Heavens

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