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FDA Puts Empagliflozin on Hold

Quality issues in the manufacturing plant prevents final approval….

The investigational type 2 diabetes drug empagliflozin won’t win the FDA’s approval until “previously observed deficiencies” at a manufacturing plant are fixed, the drug’s sponsors said last week.

Eli Lilly and Boehringer Ingelheim said the FDA had issued a complete response letter in regard to their application to market empagliflozin, a sodium glucose co-transporter-2 (SGLT-2) inhibitor.

See more SGLT-2 Resources

The drug’s mechanism is the same as for the recently approved drug dapagliflozin (Farxiga) and for canagliflozin (Invokana), causing glucose to be dumped from circulation into the urine for excretion.

A study published last year showed that empagliflozin promoted decreases both in glycated hemoglobin (HbA1c) and in body weight in a 6-month trial. Two more recent studies suggested that SGLT-2 inhibitors may increase endogenous glucose production, perhaps by some homeostatic process. But that did not appear to be an issue in the FDA’s rejection of empagliflozin.

Lilly and Boehringer Ingelheim said the agency did not ask them to conduct any new clinical trials. “The FDA stated these [manufacturing plant] deficiencies need to be resolved before the approval of the application,” the two firms said. They promised to work with agency officials to win approval as soon as possible.

Eli Lilly News Release 3-2014