FDA Approves New Drug for Treatment of Type 2 Diabetes

The US Food and Drug and Administration has announced the approval of a drug called

(dapaglifozin) to help treat adults with type 2 diabetes. The tablets, in combination with diet and exercise, are said to improve control of blood sugar levels. According to the American Diabetes Association, approximately 25.8 million people in the US have diabetes. Type 2 diabetes accounts for around 90% of these cases. Type 2 diabetes is characterized by high blood glucose (hyperglycemia). This is a result of the body being unable to produce enough insulin, or not being able to use the insulin properly (insulin resistance). High blood sugar levels can lead to serious short-term and long-term health issues, such as nerve and kidney damage, blindness and heart disease. Farxiga, a sodium-glucose co-transporter 2 inhibitor (SGLT2), works by preventing the kidney from reabsorbing glucose. This increases the excretion of glucose and reduces blood sugar levels. According to the US Food and Drug Administration (FDA), 16 clinical trials involving more than 9,400 patients with type 2 diabetes assessed the safety and effectiveness of the drug. These trials demonstrated that Farxiga was able to improve HbA1c (hemoglobin A1c or glycosylated hemoglobin) levels - a measure of blood glucose control - in type 2 diabetic patients. Commenting on the drug approval, Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II at the FDA's Center for Drug Evaluation and Research, says: "Controlling blood sugar levels is very important in the overall treatment and care of diabetes, and Farxiga provides an additional treatment option for millions of Americans with type 2 diabetes." The FDA says as well as being assessed as a stand-alone therapy, the drug has also been tested in combination with other treatments for type 2 diabetes, including insulin, pioglitazone, metformin, glimepiride, and sitagliptin.

Not suitable for patients with with bladder cancer or type 1 diabetes. Clinical trials have found that Farxiga is not suitable for individuals with type 1 diabetes, diabetic ketoacidosis (increased ketones in the urine or blood), patients with moderate or severe kidney deterioration, end-stage kidney disease, or patients receiving dialysis. Furthermore, clinical trials revealed that among users of Farxiga, there were an increased number of bladder cancers diagnosed. Therefore, the FDA recommends that patients with bladder cancer do not use the drug, and that patients with a history of the disease should consult their physician prior to using it. Dehydration was found to be a side effect of the drug. The FDA notes that elderly patients with impaired kidney function and patients using diuretics seemed to be more susceptible to this. The most common side effects from Farxiga in clinical trials were fungal infections and urinary tract infections.

With these factors in mind, the FDA have asked for six post-marketing studies to be performed. These include a cardiovascular outcomes trial (CVOT) in order to analyze how Farxiga affects patients with high risk of heart disease, and a double-blind randomized and controlled analysis of the risk of bladder cancer for patients who are a part of the CVOT trial. In other news related to diabetes, recent reports on suggest that a single faulty gene causes major type 2 diabetes symptoms in mice, while another study suggested that following a Mediterranean diet may reduce the risk of type 2 diabetes.