US FDA approves Janssen’s Invokamet XR for type 2 diabetes treatment in adults

21 September 2016 (Last Updated September 21st, 2016 18:30)

The US Food and Drug Administration (FDA) has granted approval for Janssen Pharmaceuticals' Invokamet XR to treat type 2 diabetes in adults.

The US Food and Drug Administration (FDA) has granted approval for Janssen Pharmaceuticals' Invokamet XR to treat type 2 diabetes in adults.

Invokamet XR is a once-daily, fixed-dose combination therapy of canagliflozin and metformin hydrochloride extended-release used to improve blood glucose control in adults with type 2 diabetes.

The company said that Invokana (canagliflozin) is the most prescribed sodium glucose co-transporter 2 (SGLT2) inhibitor and metformin is commonly prescribed as an initial therapy for the treatment of type 2 diabetes.

Janssen Pharmaceuticals medical affairs vice-president Paul Burton said: "The approval of Invokamet XR is further evidence of our ongoing commitment to provide new treatment options for people with type 2 diabetes.

"The approval of Invokamet XR is further evidence of our ongoing commitment to provide new treatment options for people with type 2 diabetes."

"Our Invokana portfolio now offers physicians even more choices for helping patients improve control of A1C levels and other important health measures, with numerous dosing options for monotherapy and for combination therapy with both metformin and metformin XR."

Data from Phase III studies revealed that the combination of Invokana and metformin reduces A1C significantly more than metformin alone, sitagliptin plus metformin, or glimepiride plus metformin.

Treatment with Invokana as an add-on to metformin also reduced secondary endpoints of body weight and systolic blood pressure, according to Janssen.

Invokamet is the first combination of an SGLT2 inhibitor and an immediate-release formulation of metformin and was initially approved by FDA in August 2014 to improve glycemic control in adults with type 2 diabetes not adequately controlled with metformin or canagliflozin, or who are already being treated with both medications separately.

In May this year, the FDA expanded the use of Invokamet in adults with type 2 diabetes who are not already being treated with canagliflozin or metformin.