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Canagliflozin (Invokana) Gets FDA Nod for Type 2 Diabetes

First in new class of type 2 diabetes drugs (Mar. 29)

The FDA has approved canagliflozin (Invokana, Janssen) for the treatment of adults with type 2 diabetes. Canagliflozin is the first in a new class of medications — sodium glucose co-transporter 2 (SGLT2) inhibitors — to be approved in the U.S.

Invokana (canagliflozin) is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The drug has been studied as monotherapy, in combination with metformin, and in combination with other glucose-lowering agents, including insulin, in patients who need further glucose control.

Results from phase III studies showed that canagliflozin was generally well tolerated. The most common adverse events (AEs) were genital fungal infections, urinary tract infections, and increased urination. These AEs were generally mild to moderate in intensity and rarely led to discontinuation of treatment.

The new drug application for Invokana (canagliflozin) was based on a global phase III clinical program that enrolled a total of 10,285 patients with type 2 diabetes. Results from this program showed that 100-mg and 300-mg doses of canagliflozin improved glycemic control and were associated with significant reductions in body weight and systolic blood pressure (secondary endpoints).

In two studies that compared canagliflozin with current standard treatments — sitagliptin (Januvia, Merck) in one study, and glimepiride (Amaryl, Sanofi-Aventis) in the other study — canagliflozin 300 mg provided greater reductions in hemoglobin A1C (HbA1C) levels and in body weight than either comparator. HbA1C is the percent of red-blood-cell hemoglobin with glucose attached to it and is an indicator of average blood glucose over the previous 2 to 3 months.

In studies of canagliflozin as monotherapy or in combination with agents not associated with hypoglycemia (such as metformin or metformin and pioglitazone), the incidence of hypoglycemic episodes was less than 5% across treatment groups (canagliflozin 100 mg [3.8%], canagliflozin 300 mg [4.3%], and placebo [2.2%]).

No clinical studies have established conclusive evidence of a reduction in macrovascular risk with canagliflozin or any other antidiabetic drug. Additional data are being collected to further characterize the cardiovascular profile of canagliflozin.

The FDA is requiring five postmarketing studies for Invokana (canagliflozin): 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.

Canagliflozin works by blocking the reabsorption of glucose by the kidneys, thereby increasing glucose excretion and lowering blood glucose levels in diabetics who have elevated blood glucose levels.

Sources: FDA; March 29, 2013; and Johnson & Johnson; March 29, 2013.

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