Jardiance is not for people with type 1 diabetes
Singapore: US Food and Drug Administration (FDA) has approved Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes (T2D).
Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
Jardiance, a once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2) inhibitor. 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.
"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," said Dr Christophe Arbet-Engels, vice president, metabolic-clinical development and medical affairs, BIPI. "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."
The FDA approval is based on results from a large clinical program comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D.
"Today's FDA approval of Jardiance provides an exciting new option in the treatment of adults with type 2 diabetes and demonstrates our commitment to these patients, as it marks the third diabetes medicine to emerge from our alliance pipeline," said Enrique Conterno, president, Lilly Diabetes.
