FDA Approves New Oral Drug for Type 2 Diabetes

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On August 1, the US Food and Drug Administration (FDA) approved the oral diabetes drug Jardiance (generic name empagliflozin) for use, along with a healthful diet and exercise, in adults with Type 2 diabetes. The medicine, a joint development of Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company, joins Invokana (canagliflozin) and Farxiga (dapagliflozin) as a member of the class of drugs known as sodium-glucose cotransporter 2 (SGLT2) inhibitors.

In the process of filtering the blood, the kidneys typically reabsorb all the filtered glucose and return it to the bloodstream. One of the main proteins responsible for this reabsorption is SGLT2. By inhibiting the action of SGLT2, Jardiance blocks the reabsorption of glucose by the kidneys, promoting a loss of glucose in the urine and lowering blood glucose levels.

The medicine comes in tablet strengths of 10 milligrams and 25 milligrams, to be taken once daily. The safety and effectiveness of Jardiance were established through seven clinical trials, involving 4,480 people with Type 2 diabetes, that showed improvements in fasting blood glucose levels and A1C levels (a measure of blood glucose control over the previous 2–3 months) in those taking the drug. Clinical trials also showed modest reductions in both body weight and systolic blood pressure (the top number) in people using the medicine.

In an interview with Medscape Medical News, the FDA noted that Boehringer Ingelheim had corrected manufacturing issues that initially held up approval of the medicine in March.

The FDA is requiring four trials of Jardiance once it is on the market, including one focusing on cardiovascular events; two looking at how the drug works and how safe and effective it is in children, including its effect on bone health and development; and an animal study looking at safe levels of the medicine in juveniles, with a special focus on growth and kidney and bone development.

The medicine has been studied as a stand-alone therapy and in combination with Type 2 diabetes treatments such as metformin, insulin, Actos (pioglitazone), and drugs in the sulfonylurea class. It should not be used to treat people with Type 1 diabetes, diabetic ketoacidosis (a potentially life-threatening condition marked by a chemical imbalance in the body), severe kidney impairment, end-stage kidney disease, or those on dialysis.

The most common side effects in people using this medicine are urinary tract infections and female genital infections. Because of its diuretic effect, Jardiance can cause low blood pressure, which may lead to symptoms such as dizziness, fainting, or a decline in kidney function. People who are elderly, those with impaired kidney function, and those who are on diuretics for other conditions appear to be more susceptible to this risk.

For more information, see the press releases on the Eli Lilly and FDA websites.

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