Following its U.S. Food and Drug Administration commercialization approval, Jardiance (empagliflozin) tablets are now available for sale with prescription in pharmacies across the Unites States, as well as some leading chain and independent retailers. Jardiance, which is produced by Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, is an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes.
The once-daily, 10 mg or 25 mg tablet, is a sodium glucose co-transporter-2 (SGLT2) inhibitor and works by blocking the reabsorption of glucose in the kidneys. Therefore, it raises the glucose excretion and decreases the blood glucose levels.”We believe Jardiance is an exciting new treatment option with the potential to help many of the millions of adults with type 2 diabetes who have difficulty controlling their blood sugar levels,” stated the senior vice president, marketing of Boehringer Ingelheim Pharmaceuticals, Kathleen Dowd.
“As a testament to the joint commitment by Boehringer Ingelheim and Lilly to improve care for people with diabetes, our alliance is proud to make Jardiance available so quickly following its approval by the FDA,” she added. In order to be approved by the FDA, the companies presented the results of a large clinical program composed of more than 10 multinational clinical trials and more than 13,000 adults with type 2 diabetes.
The phase III trials revealed that empagliflozin is able to reduce hemoglobin A1C, which is a measure of average blood glucose over the past two to three months, after 24 weeks as a stand-alone treatment or in combination with other background treatments, such as metformin, sulfonylureas, insulin and pioglitazone.
It has been proven effective in lowering weight or blood pressure, as well as it showed modest reductions in both weight and systolic blood pressure in clinical trials. Jardiance had already been approved by the European Commission in May and started to be commercialized also in Europe.
According to Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, the most common adverse reactions associated to the use of Jardiance are urinary tract infections and vaginal yeast infections. However, cases of hypoglycemia were also reported in patients treated with both Jardiance and sulfonylurea or insulin.
Being prescript to be used along with diet and exercise to lower blood sugar in adults with type 2 diabetes, Jardiance may be useful for approximately 29 million Americans, who suffer from the disease. It is not however indicated for people with type 1 diabetes or for people with diabetic ketoacidosis, which means increased ketones in the blood or urine. It is also not recommended for patients with severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any other ingredient present in Jardiance.