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New Diabetes Drug Approved

Darrell Hulisz, RPh, PharmD
Tom Saywell, Doct

September 2, 2014

Dapagliflozin (Farxiga®) was approved by the FDA in January 2014 to improve glycemic control in patients with type 2 diabetes mellitus as an adjunct to diet and exercise. It can be used as a sole therapy or in combination with other medications. Dapagliflozin is a member of a newer class of antihyperglycemic agents known as sodium-glucose co-transporter 2 (SGLT-2) inhibitors. The inhibition of SGLT-2 blocks renal reabsorption of glucose and increases excretion, thereby lowering blood glucose and achieving improved glycemic control. Safety and efficacy was evaluated in 16 clinical trials and improvement in HbA1c was seen with relatively few side effects. More common side effects include mycotic (fungal) infections, urinary tract infections, dehydration, orthostatic hypotension, and worsening renal function. An increased incidence of bladder cancer was noted in the trials; thus, dapagliflozin is not recommended for patients with active bladder cancer or a history of bladder cancer. The drug is contraindicated in type 1 diabetes, diabetic ketoacidosis and moderate to severe renal impairment or failure. Dapagliflozin can be utilized in patients with type 2 diabetes and adequate renal function (CrCl>60mL/min) when additional glycemic control is indicated, and it has a potential added benefit of reduction in weight and blood pressure. The drug is available in 5mg and 10mg, non-scored tablets to be dose initially 5mg once daily and increased to 10mg once daily if necessary. Use of dapagliflozin is not recommended in patients with an estimated GFR of < 60ml/min. Because of this, the drug will be limited in many patients with diabetes. Average wholesale price for this drug is $347 for a one-month supply.