Janssen Pharmaceutical’s new diabetes drug, Invokana, gets FDA approval
The U.S. Food and Drug Administration (FDA) approved a new drug to treat type 2 diabetes Friday, according to a press release March 29.
Diabetes symptoms
Public domain image/Mikael Häggström
The approved drug, the first in a new class of diabetes drugs, Invokana (canagliflozin) tablets will improve glycemic control in adults with type 2 diabetes when used with diet and exercise.
INVOKANA™ is the first in a new class of medications called sodium glucose cotransporter 2 (SGLT2) inhibitors to be approved in the United States. It is also the only oral, once-daily medication available in the United States offering improved glycemic control while also showing reduced body weight and systolic blood pressure in clinical trial, according to a Janssen Pharmaceutical press release.
“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,” said Richard Aguilar*, M.D., Medical Director, Diabetes Nation, LLC and Diabetes Care Foundation, a non-profit organization committed to improving diabetes care.
“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 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 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.
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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.
Invokana is manufactured for Janssen Pharmaceuticals, Inc., Titusville, N.J.
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