FDA Approves New Drug Invokana to Treat Type 2 Diabetes

FDA has approved a new tablet, Invokana, manufactured for Janssen Pharmaceuticals, Inc. for the treatment of type 2 diabetes.  Invokana is the first type 2 diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors.  Invokana works by blocking reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels.  The most common side effects of Invokana are vaginal yeast infection and urinary tract infections.  Because Invokana is associated with a diuretic effect, it can cause a reduction in intravascular volume leading to orthostatic or postural hypotension (a sudden fall in blood pressure when standing up). This may result in symptoms such as dizziness or fainting, and is most common in the first three months of therapy. Invokana should not be used to treat people with type 1 diabetes; in those who have increased ketones in their blood or urine (diabetic ketoacidosis); or in those with severe renal impairment, end stage renal disease, or in patients on dialysis.

The FDA is requiring five postmarketing studies for Invokana: a cardiovascular outcomes trial; an enhanced pharmacovigilance program to monitor for malignancies, serious cases of pancreatitis, severe hypersensitivity reactions, photosensitivity reactions, liver abnormalities, and adverse pregnancy outcomes; a bone safety study; and two pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

[1] FDA News Release, "FDA approves Invokana to treat type 2 diabetes" (March 29, 2013).