FDA Approve Diabetes Combo

The FDA approved a fixed-dose combination of canagliflozin and metformin hydrochloride extended release (Invokamet RX/Janssen).

The US Food and Drug Administration (FDA) approved a fixed-dose combination of canagliflozin and metformin hydrochloride extended release (Invokamet XR/Janssen).

The combo is meant for first-line use as an adjunct to diet and exercise to improve blood glucoses control in appropriate adults with type 2 diabetes.

The product combines canagliflozin with an extended release formulation of metformin.

The drug combo is mean for adults when they are first diagnosed or as additional therapy for patients whose A1C levels are not well controlled with either agent alone.

Phase 3 studies showed the combo worked better than metformin alone, sitagliptin plus meformin, or glimepiride plus metformin.

It also showed patients had greater reductions in body weight and systolic blood pressure.

Potential side effects included genital yeast infections, urinary tract infections, and lactic acidosis.

The drug combo may also increase the risk of bone fracture in some patients and longterm use could cause a decrease in vitamin B12.