New diabetes drug approved by federal advisory panel, but is it safe?

A new diabetes drug called canagliflozin has been approved by a Food and Drug Administration advisory panel. The drug, developed by Johnson & Johnson, acts to lower blood sugar by increasing the excretion rate of sugar via the kidneys into the urine of patients with Type 2 diabetes. This is a new means of controlling blood sugar the majority of other diabetes drugs work by affecting the supply or use of insulin. The FDA doesn t have to follow the advice of the expert panel, but it usually does.

Canagliflozin improved blood-sugar levels and resulted in weight loss and reductions in blood pressure in clinical trials of more than 10,000 patients worldwide. However, concerns have been raised about the possibility of serious side effects, especially in individuals with kidney disease. Concerns have also been raised about elevated stroke risk and an increase in heart attacks and other cardiovascular problems within the first 30 days of taking the medication. And although the drug did raise levels of good cholesterol (HDL), it also raised levels of bad cholesterol (LDL).

Edward W. Gregg of the Centers for Disease Control and Prevention, who voted against the approval, says, I found myself weighing a lot of maybe benefits versus a lot of maybe risks. But Dr. Peter Stein, the diabetes disease area leader for Janssen, Johnson & Johnson s pharmaceutical division, has a strong belief that canagliflozin is a medication which really offers a new option for Type 2 diabetes patients.

ACSH s Dr. Josh Bloom notes that this could represent a significant advance in the treatment of type 2 diabetes because canagliflozin acts by a novel mechanism of action. The two existing classes of oral hypoglycemic drugs act either by causing the pancreas to secrete more insulin or increasing uptake of glucose by muscle tissue, he says. Both classes have limitations so it will be interesting to see if renal excretion of glucose will prove to be a viable option.