Date Published: 29 March 2013
FDA approves Invokana to treat type 2 diabetes
The United States Food and Drug Administration (FDA) has approved Invokana (canagliflozin) tablets, used with diet and exercise, to improve glycemic control in adults with type 2 diabetes.
This product has been described as a 'first' in a new class of diabetes drugs, to treat type 2 diabetes.
Type 2 diabetes is the most common form of diabetes and affects about 24 million people, over 90% of diabetes cases diagnosed in the United States. Over time, high blood sugar levels can increase the risk for serious complications, including heart disease, blindness, and nerve and kidney damage.
" Invokana is the first diabetes treatment approved in a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors," said Mary Parks, M.D., 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."
The FDA's statement explains briefly how Invokana works, as follows: Invokana operates by blocking the reabsorption of glucose by the kidney, increasing glucose excretion, and lowering blood glucose levels in diabetics who have elevated blood glucose levels. Its safety and effectiveness were evaluated in nine clinical trials involving over 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c levels (a measure of blood sugar control) and fasting plasma glucose (blood sugar) levels.
Invokana has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, sulfonylurea, pioglitazone, and insulin. Invokana should not be used to treat people with type 1 diabetes, used to treat people who have increased ketones in their blood or urine (diabetic ketoacidosis), or used to treat anyone with severe renal impairment, end stage renal disease, or in patients on dialysis.
The FDA requires 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
- and 5. ... 2 pediatric studies under the Pediatric Research Equity Act (PREA), including a pharmacokinetic and pharmacodynamic study, and a safety and efficacy study.
The most common side effects of Invokana are vaginal yeast infection (vulvovaginal candidiasis) and urinary tract infection. 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.
Further information is available from the FDA's website.
Source: The U.S. Food and Drug Administration