The US Food and Drug Administration (FDA) has approved Jardiance (empagliflozin) tablets, developed by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, as an addition to diet and exercise to improve glycemic control in adults with type II diabetes.
Jardiance is a once-daily, 10mg or 25mg tablet that was approved in the US based on data from a large clinical programme comprising at least ten multinational clinical trials and more than 13,000 adults with type II diabetes.
In Phase III clinical trials, patients demonstrated a significant reduction in hemoglobin A1C and fasting blood sugar after 24 weeks, using Jardiance as a standalone treatment or in combination with a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone.
Urinary tract infections and vaginal yeast infections were the most common adverse reactions associated with Jardiance in these studies.
Hypoglycemia was more commonly reported in patients treated with the combination of Jardiance and sulfonylurea or insulin.
“Jardiance is a new option that has been shown in clinical trials to reduce blood sugar levels.”
Boehringer metabolic-clinical development and medical affairs vice-president Dr Christophe 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.”
Empagliflozin is a sodium glucose co-transporter 2 inhibitor that blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.
Jardiance is not for people with type I diabetes or for people with diabetic ketoacidosis.
In January 2011, Boehringer Ingelheim and Lilly announced their alliance to develop compounds for several of the largest diabetes treatment classes. Jardiance is the third diabetes medicine they have developed as part of this alliance.