FDA Approves Fixed Dose Canagliflozin/Metformin

woman holding one pill in between her thumb and index fingerThe U.S. Food and Drug Administration has approved a fixed-dose therapy combining the sodium glucose co-transporter 2 inhibitor canagliflozin and metformin hydrochloride in a single tablet for the treatment of adults with type 2 diabetes. Known as Invokamet, the agent is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus who are not adequately controlled by treatment that includes either canagliflozin or metformin, or who are already being treated with both canagliflozin and metformin as separate medications.

Approval was based on data from six Phase 3 clinical studies involving 4,732 patients with type 2 diabetes randomized to canagliflozin plus metformin versus metformin plus another diabetes therapy, according to Janssen Pharmaceuticals. Inc. The combination of canagliflozin and metformin lowered blood sugar and reduced secondary endpoints of body weight and systolic blood pressure to a greater degree than metformin alone, according to the studies.

The agent will be available in tablets containing canagliflozin 50 mg or 150 mg, and metformin 500 mg or 1,000 mg. The recommended dosing is twice daily.

The most common adverse events in clinical trials of canagliflozen were female genital mycotic infections, urinary tract infections, and increased urination. The prescribing information for canagliflozen contains a boxed warning for lactic acidosis. For metformin, diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache are listed as the most common adverse events noted in prescribing information.

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