Boehringer Ingelheim Pharmaceuticals, Inc. (BIPI) and Eli Lilly and Company have announced that Jardiance (empagliflozin) tablets are now available by prescription in pharmacies across the United States, including Walgreens, Rite Aid, Kroger and many other leading chain and independent retailers.
The US Food and Drug Administration (US FDA) approved Jardiance on August 1, 2014 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).
"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," said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "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."
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 type 2 diabetes who have elevated blood glucose levels.
Patients should not take Jardiance if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in Jardiance. Jardiance can cause some people to have dehydration (the loss of body water and salt), which may lead to a drop in blood pressure, and may cause patients to feel dizzy or faint.
The Jardiance Simple Savings co-pay support programme is available online and in many doctors' offices for patients who qualify.
The FDA approval of Jardiance was based on results from a large clinical programme comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. phase III studies showed Jardiance significantly reduced hemoglobin A1C (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 a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. Although Jardiance is not approved for lowering weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.
The most common adverse reactions associated with Jardiance were urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients treated with the combination of Jardiance and sulfonylurea or insulin.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs.
http://www.pharmabiz.com/NewsDetails.aspx?aid=83775&sid=2
The US Food and Drug Administration (US FDA) approved Jardiance on August 1, 2014 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).
"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," said Kathleen Dowd, senior vice president, marketing, Boehringer Ingelheim Pharmaceuticals, Inc. "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."
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 type 2 diabetes who have elevated blood glucose levels.
Patients should not take Jardiance if they have severe kidney problems or are on dialysis, or if they are allergic to empagliflozin or any ingredient in Jardiance. Jardiance can cause some people to have dehydration (the loss of body water and salt), which may lead to a drop in blood pressure, and may cause patients to feel dizzy or faint.
The Jardiance Simple Savings co-pay support programme is available online and in many doctors' offices for patients who qualify.
The FDA approval of Jardiance was based on results from a large clinical programme comprised of more than 10 multinational clinical trials and more than 13,000 adults with T2D. phase III studies showed Jardiance significantly reduced hemoglobin A1C (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 a range of background treatments, including metformin, sulfonylureas, insulin and pioglitazone. Although Jardiance is not approved for lowering weight or blood pressure, modest reductions in both weight and systolic blood pressure were observed in clinical trials.
The most common adverse reactions associated with Jardiance were urinary tract infections and vaginal yeast infections. Hypoglycemia was more commonly reported in patients treated with the combination of Jardiance and sulfonylurea or insulin.
In January 2011, Boehringer Ingelheim and Eli Lilly and Company announced an alliance in diabetes that centers on compounds representing several of the largest diabetes treatment classes. The alliance leverages the strengths of two of the world's leading pharmaceutical companies. By joining forces, the companies demonstrate commitment in the care of people with diabetes and stand together to focus on patient needs.
http://www.pharmabiz.com/NewsDetails.aspx?aid=83775&sid=2
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