The US Food and Drug Administration (FDA) has approved a fixed-dose combination product combining the sodium glucose cotransporter 2 (SGLT2) inhibitor canagliflozin with metformin hydrochloride for the first-line treatment of adults with type 2 diabetes.
Known as Invokamet (Janssen), this product can now be prescribed in those with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy, according to the company.
Invokamet — the first product to combine an SGLT2 inhibitor with metformin in the United States — was previously approved by the FDA in August 2014 as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes not adequately controlled by either canagliflozin or metformin or who were already being treated with both medications separately.
The new indication for Invokamet aligns with recent type 2 diabetes treatment guidelines, which recommend dual therapy for patients with higher HbA1c levels.
Specifically, guidelines recommend dual therapy for patients who have an initial HbA1c level of 7.5% or higher and for those who have an initial level below 7.5% and do not achieve an HbA1c treatment goal after about 3 months on single therapy, often metformin.
In addition, dual or triple therapy is recommended as first-line therapy in asymptomatic patients with an initial HbA1c level above 9%, Janssen notes in its statement.
Invokamet should not be used in patients with type 1 diabetes or for the treatment of diabetic ketoacidosis, it adds.
The product is available in four dose strengths, in tablets containing canagliflozin 50 mg or 150 mg and metformin 500 mg or 1000 mg. The recommended dosing is twice daily.
The prescribing information also contains a boxed warning for lactic acidosis, a rare but serious complication that can occur due to metformin accumulation.
Canagliflozin has also recently been the subject of an FDA and European Medicines Agency (EMA) warning regarding an approximately twofold risk for leg and foot amputations with the drug compared with placebo in an ongoing clinical trial and has previously been linked to a higher rate of bone fractures and a risk of diabetic ketoacidosis.
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Cite this: Canagliflozin/Metformin Combo Approved as First Line for Diabetes - Medscape - May 24, 2016.