FDA expands indication for Janssen Pharmaceuticals’ Invokamet diabetes drug

Invokamet is a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet.

The drug has now been approved as a first-line treatment for adults with type 2 diabetes who are not being treated with either canagliflozin or metformin.

Invokamet was first approved in the US in August 2014 as an adjunct to diet and exercise for enhancing 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.

The drug had initially been approved as adjunct to diet and exercise to control blood glucose levels that wasn’t being controlled adequately by either of Invokamet’s ingredients alone, or who were being treated with both medications separately.

A phase 3 study found that among patients not taking any therapy to reduce glycated hemoglobin
(A1C), those given the combination therapy at the outset had greater A1C reductions than those treated with either dose of canagliflozin (100 mg or 300 mg) or metformin separately.

The mean baseline A1C across all groups was 8.8%. The primary endpoint was the change in A1C.

Janssen vice president of medical affairs Paul Burton said: "The available doses of Invokamet allow physicians to tailor therapy for individual patient needs and offer an alternative for people living with type 2 diabetes who may be able to reduce the number of pills they take each day.

"This expansion marks an important milestone as we continue to study Invokamet and Invokana — the number-one prescribed SGLT2 inhibitor with more than 8 million prescriptions to date — for the treatment of type 2 diabetes."

Image: Invokamet is a fixed-dose therapy combining canagliflozin and metformin hydrochloride in a single tablet. Photo: courtesy of zole4/FreeDigitalPhotos.net.