FDA adds Invokana to approved diabetes treatments

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The FDA approved canaglifozin tablets, which with diet and exercise, is used to improve glycemic control in adults with type 2 diabetes.

Canaglifozin (Invokana, Johnson & Johnson) is a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. This is the first SGLT2 inhibitor treatment approved in the U.S. as a treatment of diabetes, according to the FDA.

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 that enrolled 10,285 patients with type 2 diabetes. The trials showed improvement in hemoglobin A1c levels and fasting plasma glucose levels.

Invokana should not be used to treat people with type 1 diabetes; in those who have diabetic ketoacidosis; or in those with severe renal impairment, end stage renal disease, or in patients on dialysis.

The FDA is requiring 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 two pediatric studies, including a pharmacokinetic and pharmacodynamic study and a safety and efficacy study.

The most common side effects of Invokana are vaginal yeast infection 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. This side effect is most common in the first three months of therapy.