Diabetes drug canagliflozin receives FDA approval

Diabetes drug canagliflozin (Invokana, Janssen Pharmaceuticals) is the first drug approved by FDA in a new class known as sodium-glucose co-transporter 2 (SGLT2) inhibitors 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 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, and thereby increases urinary glucose excretion. The result is a lowering of blood glucose in diabetes patients with elevated blood glucose.

"The approval of Invokana serves as another breakthrough in the battle to effectively manage and treat type 2 diabetes which continues to major public health concern. The appropriate management of the type 2 diabetes with the combinaton of diet, exercise, and now Invokana can better control blood sugar levels and potentially reduce the risk of serious complications that can be associated with the disease," said Formulary advisor Abimbola Farinde, PharmD, MS, clinical staff pharmacist at Clear Lake Regional Medical Center, in Webster, Texas.

Canagliflozin was evaluated in 9 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 A_1c 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.

FDA is requiring 5 post-marketing studies:

• a 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

• 2 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, FDA is warning about potential orthostatic or postural hypotension, which is most common within the first 3 months of treatment.

For related content see:

http://formularyjournal.modernmedicine.com/formulary-journal/news/user-defined-tags/canagliflozin/canagliflozin-emerging-treatment-option-type-