BETHESDA, MD 01 Apr 2013—
and Janssen Pharmaceuticals Inc. (PDF) on March 29 announced the approval of canagliflozin for the treatment of type 2 diabetes mellitus in adults.
Canagliflozin, a once-daily oral therapy, should be used in conjunction with diet and exercise to improve glucose control in patients with type 2 diabetes.
The drug is not recommended for use in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis. Canagliflozin is contraindicated in patients undergoing dialysis and those with severe kidney impairment or end-stage renal disease.
According to FDA, canagliflozin is a sodium–glucose cotransporter 2 inhibitor and the first drug in this class to be approved by the agency.
The for canagliflozin states that it inhibits glucose reabsorption by the kidney, resulting in increased urinary excretion of glucose.
Canagliflozin has been studied as a standalone therapy and in combination with metformin, sulfonylurea, metformin and sulfonylurea, and metformin and a thiazolidinedione, as well as in combination with insulin with or without other antihyperglycemic agents.
In clinical trials, canagliflozin improved hemoglobin A1c levels and fasting and postprandial blood glucose levels and was associated with weight loss in patients with type 2 diabetes.
The safety and efficacy of the drug were tested in nine clinical trials involving more than 10,000 patients with type 2 diabetes.
The most commonly reported adverse events in patients treated with canagliflozin in clinical trials included genital yeast infection, urinary tract infection, and increased urination. Orthostatic or postural hypotension related to the drug's diuretic effects were also reported in clinical studies and occurred most often during the first three months of treatment.
More serious risks associated with the drug's use include hyperkalemia and serious allergic reactions.
These and other risks associated with canagliflozin therapy are described in a medication guide (PDF) that must be distributed with each filled prescription.
The recommended dosage of canagliflozin is 100 mg taken once daily before the first meal of the day. The dosage can be increased to 300 mg once daily for patients who require greater glucose control and whose estimated glomerular filtration rate is at least 60 mL/min/1.73 m2.
The higher dosage may also be appropriate in patients treated concomitantly with rifampin, phenytoin, phenobarbital, ritonavir, or other drugs that induce uridine diphosphate glucuronyltransferases. Increased digoxin levels were observed in patients concomitantly treated with that drug and canagliflozin. The labeling recommends appropriate digoxin monitoring in patients taking both drugs.
Canagliflozin will be available as 100- or 300-mg tablets in bottles of 30, 90, or 500 each and in 100-tablet blister packs. The drug should be stored at controlled room temperature.
A Janssen spokesperson said the company is working to make the drug available in the United States by the end of this week.