NDA for Extended-Release Diabetes Tx Submitted
Janssen announced the submission of its New Drug Application (NDA) to the Food and Drug Administration (FDA) for once-daily Invokamet XR (canagliflozin/metformin extended-release) as a new treatment option for adults with type 2 diabetes mellitus as adjunct to diet and exercise to improve glycemic control.
Canagliflozin is currently being studied in several ongoing clinical trials, including in combination with metformin. Two studies evaluating Invokana plus metformin vs. standard treatments (eg, sitagliptin, glimepiride) plus metformin showed that the combination therapy with Invokana provided greater A1C and weight reduction than either comparator. Janssen is also evaluating the effects of canagliflozin on diabetic nephropathy progression (CREDENCE), cardiovascular safety (CANVAS), and renal endpoints and cardiovascular events risk (CANVAS-R).
Invokamet XR is a combination of canagliflozin, a sodium-glucose co-transporter 2 (SGLT2) inhibitor, and extended-release metformin, a biguanide.For more information call (800) 526-7736 or visit Janssen.com.