Janssen Research & Development has submitted a New Drug Application (NDA) to the US FDA seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes.
Canagliflozin, a selective sodium glucose co-transporter 2 inhibitor, blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.
Metformin may be used alone or with other medications including insulin to lower blood glucose levels in type 2 diabetic treatment while Canagliflozin is an investigational oral medication used for the same.
On approval, both the canagliflozin and metformin medications can be fixed in one pill.
Janssen has submitted NDA based on the global phase 3 clinical development program for canagliflozin.
