Boehringer, Eli Lilly’s Jardiance gets FDA approval for diabetes treatment

The approval was given after reviewing results from a large clinical program which included over ten multinational clinical trials and more than 13,000 adults with T2D.

The Phase III trials showed Jardiance reduced hemoglobin A1C (a measure of average blood glucose over the past two to three months) and fasting blood sugar after 24 weeks as a stand-alone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone.

Jardiance, a sodium glucose co-transporter 2 (SGLT2) inhibitor, is not indicated for people with type 1 diabetes or with diabetic ketoacidosis (increased ketones in the blood or urine).

The once-daily, 10 mg or 25 mg tablet, Jardiance, works by blocking the reabsorption of glucose in the kidney, increasing glucose excretion and lowering blood glucose levels in adults with T2D who have elevated blood glucose levels.

Jardiance can cause dehydration, which can lead to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function.

Boehringer Ingelheim Pharmaceuticals vice president of metabolic-clinical development and medical affairs Christophe Arbet-Engels said many adults with type 2 diabetes still have difficulty controlling their blood sugar levels even with treatment.

"There is a critical need for new treatment options to help these patients," Arbet-Engels said.

"Jardiance is a new option that has been shown in clinical trials to reduce blood sugar levels. Although not approved for weight loss, modest weight loss was also observed in these clinical trials."

Image: Jardiance (empagliflozin) 10 mg tablets secured FDA approval based on Phase III trials carried out on patients with type 2 diabetes. Photo: courtesy of PRNewsFoto/Eli Lilly and Company.