March 31, 2013
New Class Of Diabetes Drug Approved By The FDA
redOrbit Staff & Wire Reports - Your Universe Online
The US Food and Drug Administration (FDA) approved Invokana, the first of a new class of drugs that will treat patients suffering from type 2 diabetes, on Friday, various media outlets have reported.
“Invokana, or canagliflozin, is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors,” Dr. Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said in a statement.
“We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health,” she added.
The FDA studied five postmarketing studies for the medication, including a cardiovascular outcomes trial, an enhanced pharmacovigilance program, a bone safety study and two pediatric studies, Reuters reporter Toni Clarke explained.
Those trials showed that Invokana was effective in lowering the blood sugar of patients suffering from type 2 diabetes — the most common form of the disease. However, there were some possible side effects.
“Earlier this year, an advisory committee to the FDA discussed the benefits and risks of canagliflozin with a focus on any potential increased risk of heart attack or stroke,” Clarke said.
“A clinical study of patients at especially high risk of cardiovascular disease showed that within the first 30 days, 13 patients“¦ suffered a major cardiovascular event compared with just one patient taking a placebo. After that, the imbalance was reversed,” she added. “The drug also caused a slight increase in unhealthy LDL cholesterol.”
An FDA spokesperson told the New York Times that the significance of those findings was “unclear,” and that there would be no requirement to place warnings about heart attacks or strokes required on the label.
The US health agency added that the most common side effects with Invokana were vaginal yeast infections and urinary tract infections. Furthermore, the drug is not recommended for patients suffering from severe kidney disease, as they were found to be at a higher risk for negative side effects versus those with normal renal functions.