FDA Panel Votes Against Lilly-Boehringer Ingelheim`s Diabetes Drug

By Reuters Staff

(Reuters) - Independent experts on an FDA advisory panel on Wednesday voted against the use of an already approved diabetes drug from Eli Lilly and Co and Boehringer Ingelheim as an add-on to insulin therapy in patients with type 1 diabetes.

The drug, empagliflozin, was approved in 2014 in doses of 10 mg and 20 mg to help lower blood sugar levels in patients with type 2 diabetes and is marketed as Jardiance.

Empagliflozin, like Johnson & Johnson's Invokana (canagliflozin) and AstraZeneca Plc's Farxiga (dapagliflozin), are SGLT2 inhibitors, which lower blood sugar by increasing the excretion of glucose through urine.

However, SGLT2 inhibitors have been linked to the risk of diabetic ketoacidosis (DKA) in higher doses.

DKA, an inherent complication associated with type 1 diabetes, is a life-threatening condition in which acids called ketones build up when the body starts to use fat instead of glucose as a source of energy.

The increased risk of DKA was highlighted during an FDA advisory committee meeting on Sanofi SA and Lexicon Pharmaceuticals' sotagliflozin, an SGLT1 and SGLT2 dual inhibitor in type 1 diabetes, following which the health regulator declined to approve the treatment.

Boehringer Ingelheim has proposed a 2.5 mg dose of empagliflozin for use in type 1 diabetes to help lower the risk of DKA.

The panel voted 14-2 against when asked whether the available data show that the treatment's benefits outweigh its risks.

The FDA is yet to take a decision on empagliflozin's use in type 1 diabetes. While the agency is not bound to follow the recommendation of its advisory panels, it usually does so.

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