The FDA has approved canagliflozin (Invokana, Janssen), the first in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors endorsed, to treat type 2 diabetes in conjunction with diet and exercise.
Canagliflozin is the only treatment approved for diabetes that does not have an effect on insulin. Instead it blocks the kidney from reabsorbing glucose, thereby increasing glucose excretion in urine and lowering levels in the blood.
“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, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research, said in a press release.
As part of the approval, drug-maker Janssen Pharmaceuticals is required to conduct four post-marketing studies — one to assess cardiovascular outcomes, one to assess bone safety and two pediatric trials. The FDA is also requiring Janssen establish a program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abormalities and adverse pregnancy outcomes associated with canagliflozin.
Drug approval was based on results from nine clinical trials involving more than 10,285 patients with type 2 diabetes. The studies showed significant improvement in glycated hemoglobin (HbA1c) levels and fasting plasma glucose among patients assigned to canagliflozin vs. placebo, and demonstrated noninferiority to other common diabetes drugs, glimepiride (Amaryl) and sitagliptin (Januvia).
The two most common side effects associated with canagliflozin are vaginal yeast infection and urinary tract infection.
Due to a diuretic effect, canagliflozin can cause a reduction in intravascular volume that may lead to orthostatic or postural hypotension, the FDA warned. This may symptoms such as dizziness or fainting, most commonly in the first three months of therapy.
Canagliflozin is not approved for patients with type 1 diabetes. It is contraindicated in those who have increased ketones in their blood or urine, as well as in patients with severe renal impairment, end stage renal disease or those on dialysis.