Farxiga — the once-a-day tablet aimed to treat type 2 diabetes — received approval from the Food and Drug Administration (FDA) on Wednesday after 16 clinical trials involving more than 9,400 patients.
The medicine manufactured by Bristol-Myers Squibb and AstraZeneca claims to use a new approach to reduce blood sugar levels. “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,” said Dr. Curtis Rosebraugh, director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research in the news release.
How Farxiga Works
The tablet eliminates excess sugar via the patient’s urine rather than older drugs that decrease sugar absorbed from food and stored in the liver. The selective and reversible sodium-glucose co-transporter 2 (SGLT2) inhibitor — which works independently of insulin — blocks the reabsorption of sugar by the kidney, increases sugar excretion, and thus lowers blood sugar levels. The diabetes drug is also found to provide the additional benefit of weight loss, which may draw patients' attention since type 2 diabetes is associated with obesity.
Type 2 Diabetes and Obesity
Type 2 diabetes accounts for up to 95 percent of diabetes cases and is usually closely connected with older age, obesity, and physical inactivity, family history of the condition, or a personal history of gestational diabetes, according to the Centers for Disease Control and Prevention. The occurrence of diabetes and obesity have become large public health concerns in the 21st century with percentage rates for both conditions increasing six percent and 57 percent, respectively.
Being overweight or obese could prevent the body’s ability to maintain proper blood sugar levels. The body can become resistant to insulin and the prolonged effects of this resistance could highly lead to the development of the condition. Therefore, the more fatty tissue a person has, the more resistant their cells become to insulin.
Farxiga and Bladder Cancer Risk
Although Farxiga aims to improve glycemic control in adults, along with diet and exercise, the drug poses serious health risks such as bladder cancer. Initially in January 2012, the FDA had rejected the type 2 diabetes treatment after FDA advisors raised concern about its bladder and breast cancer risk. New data provided by the Bristol-Myers Squibb in December 2013 showed the benefits of the medicine appeared to outweigh its risks, Reuters reported.
However, some FDA advisors expressed concern over 10 patients who took the drug dapagliflozin — now known as Farxiga — in a large trial and were later diagnosed with bladder cancer. Advocates for Farxiga argued six of those cases occurred within months after treatment began and was probably not related to the drug since the cancer commonly takes years to develop. "I don't think we can dismiss it," said panel member Dr. Milton Packer, a cardiologist and chairman of clinical sciences with the University of Texas Southwestern Medical Center in Dallas.
The FDA now warns consumers Farxiga is not recommended for patients with active bladder cancer, and those with a history of bladder cancer should talk to their physician before using the diabetes drug. Other health risks that such as cardiovascular disease have to be reevaluated during six post-marketing studies to make sure the drug doesn’t increase a patient’s risk of heart attacks in those who are already at high risk. The drug should not be used to treat people with type 1 diabetes, those who have increased ketones in their blood or urine (diabetic ketoacidosis), or those with moderate or severe renal impairment, end stage renal disease, or patients on dialysis, says the FDA.
The common side effects observed in clinical trials include genital mycotic, fungal infections, and urinary tract infections.
Farxiga tablets may potentially treat the 24 million people in the U.S. who suffer from type 2 diabetes by regulating their blood sugar levels and facilitating diet and exercise in adults.