FDA gives new approval for Invokamet (canagliflozin+metformin) in type 2 diabetes- Janssen

The FDA has approved Invokamet, a fixed-dose combination therapy of Invokana (canagliflozin) and metformin hydrochloride, from Janssen Pharmaceuticals, for first-line treatment of adults with type 2 diabetes. With this new approval, Invokamet may now be prescribed in adults with type 2 diabetes who are not already being treated with canagliflozin or metformin and may benefit from dual therapy. The expanded indication was based largely on a 26-week, double-blind, active-controlled, multicenter Phase III study in 1,186 adults with type 2 diabetes inadequately controlled with diet and exercise, and who had not been treated previously with any glucose-lowering medications. The primary endpoint was the change in A1C. Results were published in Diabetes Care in 2016.

Invokamet, the first combination of a sodium glucose co–transporter 2 (SGLT2) inhibitor and metformin available 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 are already being treated with both medications separately.

Comment: The new indication aligns with recent type 2 diabetes treatment guidelines, which recommend dual therapy for patients with higher A1C levels. Specifically, guidelines recommend dual therapy for patients who have an initial A1C level of 7.5 percent or higher; and for those who have an initial level below 7.5 percent and do not achieve an A1C treatment goal after about three months on single therapy, often metformin. In addition, dual or triple therapy is recommended as first-line therapy in asymptomatic patients with an initial A1C level above 9 percent.