New Diabetes Rx Approved

Farxiga SGLT2 inhibitor approved to treat type 2 diabetes by FDA

/ Author:  / Reviewed by: Joseph V. Madia, MD Beth Bolt, RPh

(RxWiki News) Diabetes is a common condition in the US, with plenty of patients looking for different treatment options. One new option for these patients has just been approved.

This week, the US Food and Drug Administration (FDA) announced approval of the medication dapagliflozin (brand name Farxiga) to treat type 2 diabetes.

Diabetes patients are urged to use lifestyle choices like diet and exercise alongside medications to manage their condition.

"Move around and stay active during the day."

On January 8, FDA announced that Farxiga is now approved to help with glycemic control, or management of blood sugar, in patients with type 2 diabetes.

According to the American Diabetes Association (ADA), type 2 diabetes develops when the body does not use the hormone insulin correctly, leading to high blood sugar (glucose).

FDA reported that Farxiga, which is a type of medication called a sodium-glucose co-transporter 2 (SGLT2) inhibitor, works to stop the kidneys from reabsorbing glucose, increases the body's excretion of glucose and lowers blood glucose levels. FDA noted that Farxiga should be used alongside diet and exercise.

According to FDA, the medication, which is sold by Bristol-Meyers Squibb Company and AstraZeneca Pharmaceuticals, has been tested in 16 clinical trials that involved over 9,400 type 2 diabetes patients.

These studies did show higher rates of bladder cancers in patients using Farxiga. Based on these findings, the FDA is not recommending the medicine for people with active bladder cancer and suggests that patients with a history of the condition discuss the matter with their doctor.

"Farxiga can cause dehydration, leading to a drop in blood pressure (hypotension) that can result in dizziness and/or fainting and a decline in renal function," FDA noted. "The elderly, patients with impaired renal function, and patients on diuretics to treat other conditions appeared to be more susceptible to this risk."

In an FDA news release, Curtis Rosebraugh, MD, MPH, of the FDA’s Center for Drug Evaluation and Research, highlighted the importance of this announcement.

“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. Rosebraugh.

The ADA noted that it is important for patients to stay abreast of the latest developments.

"Diabetes is a common disease, yet every individual needs unique care," said ADA. "We encourage people with diabetes and their families to learn as much as possible about the latest medical therapies and approaches, as well as healthy lifestyle choices."

Review Date: 
January 8, 2014
Last Updated:
January 9, 2014