FDA Approves 1st in New Class of Type 2 Diabetes Drugs03/29/13
FRIDAY, March 29 (HealthDay News) -- The first in a new class of
type 2 diabetes drugs was approved Friday by the U.S. Food and Drug
Invokana (canaglifozin) tablets are to be taken, in tandem with
a healthy diet and exercise, to improve blood sugar control in
adults with type 2 diabetes.
Invokana belongs to a class of drugs called sodium-glucose
co-transporter 2 (SGLT2) inhibitors. It works by blocking the
reabsorption of glucose (sugar) by the kidney and increasing
glucose excretions in urine, the FDA said in a news release.
"We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health," Dr. Mary Parks, director of the division of metabolism and endocrinology products in the FDA's Center for Drug Evaluation and Research, said in the news release.
About 24 million Americans have type 2 diabetes, and it accounts
for more than 90 percent of diabetes cases diagnosed in the United
States, the FDA said. If blood sugar levels are not carefully
controlled, there is an increased risk for serious complications,
including heart disease, blindness, and nerve and kidney damage,
the agency added.
The FDA approval is based on the findings of nine clinical
trials involving more than 10,000 patients. Patients who took the
drug showed improvement in hemoglobin A1c levels (a measure of
blood sugar control) and fasting blood sugar levels.
Invokana should not be used by people with type 1 diabetes or
people with type 2 diabetes who have increased ketones in their
blood or urine (diabetic ketoacidosis), severe kidney disease,
kidney failure or who are on dialysis, the FDA said.
The agency told drug maker Janssen Pharmaceuticals that it must
conduct five post-approval studies of the drug to determine the
risk of problems such as heart disease, cancer, pancreatitis, liver
abnormalities and pregnancy complications.
The most common side effects of Invokana are vaginal yeast
infections and urinary tract infections. It may also cause
dizziness and fainting.
The U.S. National Institute of Diabetes and Digestive and Kidney
Diseases has more about
type 2 diabetes.
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