FDA Denies Empagliflozin Approval, Citing Facility Concern

Miriam E. Tucker

March 05, 2014

The US Food and Drug Administration (FDA) has declined to approve the glucose-lowering drug empagliflozin, citing concerns about the manufacturing facility.

Boehringer Ingelheim Pharmaceuticals Inc and Eli Lilly and Company jointly announced that the FDA issued a complete response letter for the new drug application of empagliflozin, an investigational sodium glucose cotransporter 2 (SGLT2) inhibitor.

The letter referenced deficiencies at the Boehringer Ingelheim facility where empagliflozin was to be manufactured, stating that those deficiencies need to be resolved before the application for empagliflozin can be approved. The FDA has not asked Boehringer Ingelheim to conduct any new clinical trials, according to the companies' statement.

"Boehringer Ingelheim and Lilly are committed to working with the FDA to make empagliflozin available to adults with type 2 diabetes and submitting a response to the complete response letter as soon as possible," the joint statement says.

Empagliflozin was in line to become the third oral SGLT2 inhibitor on the US market. The agents work by increasing urinary glucose excretion, with a consequent lowering of plasma glucose levels, which is accompanied by weight loss.

Canagliflozin was the first of these agents to be approved in the United States at the end of March last year; another, dapagliflozin (Farxiga, AstraZeneca/BMS), was also recently cleared by the FDA in its second attempt. Both drugs are available in Europe, where empagliflozin is also under regulatory review.

Ipragliflozin (Sugat, Astellas Pharma and Kotobuki Pharmaceutical) is the first SGLT2 inhibitor to be approved for use in Japan.

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