January 10, 2014
FDA Approves Novel AstraZeneca, Bristol-Meyers Squibb Diabetes Drug
Ranjini Raghunath for redOrbit.com - Your Universe Online
Farxiga, however, belongs to an emerging class of diabetes drugs called SGLT-2 inhibitors. These drugs work by stopping patients’ kidneys from taking sugar back from the urine, thereby increasing sugar disposal from the body.
SGLT-2 drugs are an “attractive alternative” to other diabetes drugs as they helped patients lose weight in clinical trials in addition to reducing excess sugar, Damien Conover, an independent research analyst told Reuters. Farxiga sales could hit $1.5 million by 2018, he predicted.
The FDA tested the drug on more than 9,400 Type 2 diabetic patients in 16 clinical trials and found that they showed improvement in blood sugar control. The agency tested the drug’s effect both separately and in combination with other diabetes drugs such as metformin.
Mild side effects such as dehydration and dizziness were observed in some patients. Genital and urinary tract infections were the most common side effects, the FDA reported.
The FDA also warned patients with bladder cancer or poor kidney control to check with their doctor before taking the drug. Patients with Type 1 diabetes or those on dialysis should not use the drug either, the FDA warned.
The agency also outlined six clinical trials to be carried out after the drug has begun being marketed commercially.
In 2011, the FDA initially rejected the new drug, requesting more data on its safety. In April 2012, however, the European Medicines Agency approved the drug, stating that its benefits outweighed the risks. The drug is already being sold in many European countries.
“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,” Curtis Rosebraugh, of the FDA’s Center for Drug Evaluation and Research, said in a statement.