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FDA rejects approval of empagliflozin for type 1 diabetes

A committee of the US Food and Drug Administration (FDA) has recommended against the approval of type 2 diabetes drug empagliflozin for the treatment of type 1 diabetes.

Empagliflozin, marketed under the trade name Jardiance, was rejected for approval by the committee over concerns regarding increased risks of diabetic ketoacidosis (DKA).

Empagliflozin is a drug within a class of medications known as SGLT2 inhibitors. These drugs work to lower blood sugar levels by inhibiting reabsorption of glucose in the kidneys. They were designed for type 2 diabetes and have been licensed for that condition since 2014, but studies have shown benefits in type 1 diabetes.

Two of the drugs in this class, dapagliflozin (trade name Forxiga) and sotagliflozin (Zynquista), have been approved by the European Commission for type 1 diabetes. However, the US FDA has been more cautious and is yet to approve any SGLT2 inhibitors for use in people with type 1 diabetes.

In the latest rejection, officials voted against empagliflozin for type 1 diabetes by 14 votes to 2 citing limited data around safety, particularly an increased risk of DKA in type 1 diabetes. A call for more longer-term research in bigger groups was made by the panel.

The data that was submitted for the approval process was a single clinical trial involving 241 people with type 1 diabetes, which is a relatively small number of participants.

Dr Jack A. Yanovski, who is a pediatric endocrinologist and a panellist, said: “I think we have insufficient data on the benefits and the risks of this drug.”

Fellow panellist, Dr James De Lemos added: “I’m just completely unconvinced by the data provided because it’s too small and too short an exposure period.”

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