The Food and Drug Administration has approved the entry of dapagliflozin, a drug for treating type 2 diabetes, into the U.S. market.
Dapagliflozin, manufactured by Bristol-Myers Squibb and AstraZeneca, will be sold under the brand name Farxiga.
The drug belongs to a new class of type 2 medications called SGLT-2 (sodium glucose co-transporter 2) inhibitors that block the reabsorption of glucose by the kidney and sends it to the urinary tract. By helping the body excrete glucose, the drug lowers blood sugar levels.
However, the FDA’s approval is not unconditional. The agency has told Bristol-Myers and AstraZeneca that they must conduct six post market-introduction studies to bolster the drug’s safety profile. They include:
• an outcomes trial in patients with cardiovascular disease risks
• a bladder cancer risk trial
• an animal study of drug-induced urinary flow and bladder tumor risk
• two trials on risks children
• a program to study liver abnormalities and effects on pregnancy
Dapagliflozin is not the first SGLT-2 inhibitor on the U.S. market. In 2012, the FDA approved Janssen Pharmaceutical’s Invokana, an SGLT-2 inhibitor called canagliflozin.
The drug was tested in 16 clinical trials that involved more than 9,400 type 2 patients. It should not be taken at all by type 1 patients, or by type 2s who have a high presence of ketones in their blood or urine, any sort of renal impairment, end-stage renal disease, or are on dialysis. Bladder cancer patients also cannot take dapagliflozin.
A Personal Note
Over the past four years, I have been involved in two Phase 3 studies of dapagliflozin. The first study, which ended in early 2012, was aimed at seeing how the drug affected my A1c’s. Over the course of my one-year participation in the study, my A1c dropped 0.5% and I lost 10 lbs. of weight. I experienced no side effects, and was not even aware that I was visiting the bathroom once or twice more often each day.
I had been told that some weight loss was typical for most users of the drug. But I can’t say that my drop in A1c numbers or slight weight loss could be attributed to dapagliflozin. In conjunction with taking the drug, I also followed a diet and exercise routine designed to control blood sugars.
My second participation in a dapagliflozin study started six months ago (mid-July, 2013) and is slated to last six years. It’s the study on cardiovascular outcomes, namely, do dapagliflozin users run a higher risk of heart attack or stroke from taking the drug?
I volunteered for the study because of my first good experience with the drug and because my endocrinologist is a humorous, fascinating, well-read man who does as much as anybody to keep me plugged in to diabetes research. A third reason is that I’m complimented that the people conducting the study are confident that I, a man in his 60s, will still be around in 2019.