The FDA gives nod to Invokana, a new class of type 2 diabetes medication.
Invokana, the first in a new class of type 2 diabetes drugs, has been approved by the U.S. Food and Drug Administration.
Taken in conjunction with a healthy diet and exercise, the tablets work by blocking the reabsorption of sugar by the kidney and increasing glucose excretions in urine. “We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health,” Mary Parks, M.D., director of the division of metabolism and endocrinology products in the FDA’s Center for Drug Evaluation and Research, said in an FDA release.
The Invokana approval is based on nine clinical trials of more than 10,000 patients, but the drug is not designed for people with type 1 diabetes or those with type 2 diabetes who have increased ketones in their blood or urine, severe kidney disease, kidney failure or who are on dialysis, the FDA said.
According to the FDA, roughly 24 million Americans have type 2 diabetes, and it accounts for more than 90 percent of diabetes cases. Uncontrolled blood sugar levels can lead to increased risk for serious diabetes complications, including heart disease, blindness, and nerve and kidney damage.