By: Sang Hyo Kim, Staff Editor
On March 29th 2013, the U.S Food and Drug Administration approved canagliflozin (Invokana®), a new form of a diabetic drug for patients with type 2 diabetes mellitus.1 Canagliflozin is in a new class of medications called sodium glucose co-transporter 2 (SGLT2) inhibitors and is the only oral, once-daily medication that has demonstrated to improve glycemic control, and reduce body weight and systolic blood pressure in clinical trials.1 Invokana®, manufactured by Johnson & Johnson, is different from existing drugs in that it causes excess blood sugar to be excreted in the urine rather than affecting the supply or use of insulin in the pancreas.2
Type 2 diabetes mellitus is a chronic condition that affects the body’s ability to metabolize glucose and is characterized by impaired pancreatic beta cell function that cannot keep up with the body’s demand for insulin.1 Approximately 26 million Americans have diabetes, of which 90 to 95 percent is type 2.1 According to the U.S national data from 2007 to 2010, nearly half of the adults with type 2 diabetes did not achieve recommended levels of glucose control.1
Canagliflozin works by inhibiting sodium glucose co-transporter 2 (SGLT2), an important carrier responsible for the reabsorption of glucose from the kidneys back into the bloodstream.1 As canagliflozin inhibits SGLT2, it promotes the loss of glucose in the urine, thus lowering blood glucose levels.1 Though one of the many symptoms of diabetes has known to be glucose in the urine, canagliflozin reflects an alternative approach to treatment.
The safety and efficacy of canagliflozin were tested in nine clinical trials, involving over 10,285 patients with type 2 diabetes.3 The trials showed that canagliflozin improved hemoglobin A1C levels, a measure of blood sugar control.3 Results further showed that 100 mg and 300 mg doses of Invokana® improved the patient’s glycemic control and, at some prespecified secondary endpoints, patients had significant reduction in body weight and systolic blood pressure.1When comparing canagliflozin to current standard treatments such as sitagliptin (Januvia®) and glimepiride (Amaryl®), Invokana® dosed at 300 mg had a greater reduction in A1C levels and body weight than either competitor.1
Despite positive outcomes, canagliflozin showed some disadvantages during the trials. Although canagliflozin raised levels of HDL, or “good cholesterol”, it also raised levels of LDL, also known as “bad cholesterol.” The clinical trials also revealed signs of stroke risk and experiences of small heart attacks in patients taking the medication during the first thirty days. According to an F.D.A spokesman, however, warnings of increased stroke/heart attack risk do not appear on the label because the significance of the findings are unclear.To further evaluate these adverse effects, the F.D.A is requiring Johnson & Johnson to implement five post-marketing studies.2
Canagliflozin is not for patients with type 1 diabetes or diabetic ketoacidosis.4 It is also not known yet if canagliflozin is effective in patients that are eighteen years of age and younger.4 People with moderate to severe kidney disease should not take cangliflozin since there is a higher risk for negative side effects compared to people with normal kidney function. 2 The major side effects of canagliflozin include vaginal infections, penis yeast infections, urinary tract infections and increased frequency of urination.2,4 Because of canagliflozin’s diuretic effect, it can cause reduction in intravascular volume, which may lead to orthostatic or postural hypotension and/or sudden drops in blood pressure when standing up during the first three months of therapy.3 Canagliflozin is a prescription medicine designed to be used in adjunct to diet and exercise to lower blood sugar. Follow ups with one’s doctor is necessary as the results of blood tests may dictate dosage adjustments.
Due to its infancy on the market, we cannot say with certainty what doses of Invokana® will be commonly prescribed to diabetic patients. Last year, the FDA rejected another drug in the class of SGLT2 inhibitors called dapagliflozin because of its adverse effects, including increased risk for breast and bladder cancers.2 However, dopagliflozin was approved in Europe in November under the trade name of Forxiga®..2 Johnson & Johnson is also seeking approval in Europe for Invokana®, which was first licensed by Mitsubishi Tanabe Pharma Corporation in Japan.2
Wall Street predicts that canagliflozin can increase profits for Johnson & Johnson. According to Lawrence Biegelsen from Wells Fargo, an American multinational banking and financial services holding company with operations around the world, the drug can bring in an estimate of $111 million in 2013 and up to $667 million by 2016.2 These statistics show that canagliflozin will compete with the rest of the diabetic treatments in the pharmaceutical industry. However, healthcare providers must see beyond the profits and carefully observe for adverse reactions and whether canagliflozin will improve a patients’ quality of life.
- U.S FDA Approves INVOKANA ™ (Canagliflozin) for the Treatment of Adults with Type 2 Diabetes. Johnson&Johnson. http://www.jnj.com/news/all/us-fda-approves-invokana-canagliflozin-for-the-treatment-of-adults-with-type-2-diabetes. Accessed August 4th, 2014
- Thomas and Pollack, Andrew. F.D.A Approves a New Diabetes Drug from J.&J. The New York Times. http://www.nytimes.com/2013/03/30/business/invokana-wins-fda-approval-for-diabetes-treatment.html?_r=0 .Published March 29th, 2013. Accessed August 3rd 2013
- FDA approves Invokana to treat type 2 diabetes. U.S. Food and Drug Administration. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345848.htm. Accessed Published March 29th, 2013. Accessed August 3rd, 2013
- Imagine a new way forward.invokana canagliflozin tablets. http://www.invokana.com/.Accessed August 3rd, 2013