FDA approves Invokana to treat type 2 diabetes
First in a new class of diabetes drugs
On March 29, 2013, the United States Food and Drug
Administration (FDA) approved Invokana (canagliflozin) tablets, used with diet
and exercise, to improve glycemic control in adults with type 2 diabetes.
Type 2 diabetes is the most common form of the disease,
affecting about 24 million people and accounting for more than 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.”
Invokana works 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 9 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; 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 5 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 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 3 months of therapy.
Invokana is manufactured for Janssen Pharmaceuticals, Inc.,
Titusville, N.J.
Additional information can be found at the following
website: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm345848.htm
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