FDA approval marks new drug class for type 2 diabetes

Canaglifozin (Invokana, Janssen Pharmaceuticals) tablets, recently approved by the U.S. Food and Drug Administration (FDA) for the improvement of glycemic control in adults with type 2 diabetes, is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. 

The drug blocks the reabsorption of glucose by the kidney, increases glucose excretion, and lowers blood glucose levels. Safety and effectiveness of canaglifozin were evaluated in nine clinical trials and showed improvement in hemoglobin A1c levels and fasting plasma glucose levels.

It has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies, such as insulin. The drug is not intended to treat type 1 diabetes.

Common side effects are vaginal yeast infection and urinary tract infection. Canaglifozin also can cause a reduction in intravascular volume, leading to orthostatic or postural hypotension, which may result in dizziness or fainting most common in the first 3 months of therapy. 

The FDA is requiring five postmarketing studies for canaglifozin: a cardiovascular outcomes trial, an enhanced pharmacovigilance program, a bone safety study, and two pediatric studies under the Pediatric Research Equity Act.

Janssen Pharmaceuticals; (800) 526-7736; www.janssenpharmaceuticalsinc.com/