Diabetes drug canagliflozin (Invokana, Janssen Pharmaceuticals) is the first drug approved by the FDA in a new class known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. The drug is to be used as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes, according to Mary Parks, MD, director of the Division of Metabolism and Endocrinology Products in the FDA’s Center for Drug Evaluation and Research.
“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. Parks said in an FDA statement.
Canagliflozin, approved March 29, reduces the reabsorption of filtered glucose by the kidney and lowers the renal threshold for glucose, thereby increasing urinary glucose excretion. The result is a lowering of blood glucose in diabetes patients with elevated blood glucose.
Canagliflozin was evaluated in nine clinical trials that included more than 10,000 patients with type 2 diabetes. It was studied as a monotherapy and in combination with other diabetes agents including metformin, sulfonylurea, pioglitazone, and insulin. The trials demonstrated significant improvement in hemoglobin A1c levels and fasting plasma glucose with canagliflozin compared with placebo, and noninferiority to glimepiride and sitagliptin.
However, cangliflozin should not be used in patients with type 1 diabetes, in patients with increased ketones in their blood or urine, or in individuals with severe renal impairment, end-stage renal disease, or in patients with dialysis, according to the FDA statement.
The FDA is requiring five post-marketing studies:
Cardiovascular outcomes trials
A pharmacovigilance program to monitor for malignancies, severe pancreatitis cases, severe hypersensitivity and photosensitivity reactions, liver problems, and adverse pregnancy outcomes
A bone safety study
Two pediatric trials under the Pediatric Research Equity Act
During the clinical trials, the most common side effects seen with canagliflozin were vulvovaginal candidiasis and urinary tract infections. In addition, the FDA is warning about potential orthostatic or postural hypotension, which is most common within the first three months of treatment.