Advisory Committee Rejects Boehringer Ingelheim’s Empagliflozin for Type 1 Diabetes
An FDA advisory committee voted to turn down Boehringer Ingelheim’s empagliflozin oral tablets in 2.5 mg doses for type 1 diabetes.
By a 14-2 vote, the committee found that the data the company presented did not support approval of the drug in combination with insulin for glycemic control in adults with type 1 diabetes.
BI presented the results of a randomized, placebo-controlled phase 3 clinical trial of 241 patients who took the drug for 26 weeks, which showed a small reduction in blood sugar compared to pramlintide, the only approved adjunct therapy for type 1 diabetes. However, the trial also revealed an increase in diabetic ketoacidosis compared to placebo.