Type 2 diabetes affects approximately 24 million Americans. Patients eventually tend to have complications from high blood sugar levels, including kidney damage, nerve damage, blindness and heart disease.
Mary Parks, M.D., director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research, said:
"Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health."
Invokana stops the kidney from reabsorbing glucose, increasing glucose excretion, and reducing blood glucose levels in patients with diabetes who have excessively high blood glucose levels.
Richard Aguilar, M.D., Medical Director, Diabetes Nation LLC and the Diabetes Care Foundation, said "Patients with type 2 diabetes struggle managing their blood sugar, and nearly half of adults with type 2 diabetes do not achieve recommended levels of glucose control, increasing their risks for potentially life-threatening complications. Invokana is thought to work differently than other currently-available medicines because it reduces blood glucose by acting on the kidneys as a 'glucuretic,' increasing the loss of glucose in the urine. What has historically been viewed as a sign of diabetes - glucose in the urine - may also reflect the efficacy of a new and unique approach to treatment."
Invokana's safety and efficacy were assessed in nine clinical trials involving 10,285 type 2 diabetes patients. Patients on Invokana experienced improved A1c levels and fasting blood sugar (plasma glucose) levels. In Phase III studies, Invokana was also associated with reductions in body weight and systolic blood pressure.
Invokana has been studied as therapy to be taken on its own, and also in combination with, pioglitazone, sulfonylurea, metformin and insulin.
Invokana should not be used for patients with:
- Type 1 diabetes
- Diabetic ketoacidosis - ketones in their urine or blood
- Severe renal (kidney) impairment
- End stage kidney disease
- On dialysis
- A cardiovascular outcomes trial to check for liver abnormalities, photosensitivity reactions, adverse pregnancy outcomes, malignancies, severe hypersensitivity reactions, and serious cases of pancreatitis.
- A bone safety study
- Two studies on children under the Pediatric Research Equity Act (PREA). These should include a safety and efficacy study and a pharmacokinetic and pharmacodynamic study.
Invokana's diuretic effect can cause a sudden fall in blood pressure when the patient stands up (postural or orthostatic hypotension) - symptoms include fainting or dizziness. This is more common during the first twelve weeks of therapy.
Invokana is made by Janssen Pharmaceuticals, Inc., Titusville, N.J.
One month ago the FDA approved Nesina (alogliptin) tablets, Oseni (alogliptin and pioglitazone) tablets, and Kazano (alogliptin and metformin hydrochloride) tablets, to improve blood sugar control.