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Janssen Research & Development Submits New Drug Application to U.S. FDA for Canagliflozin/Metformin Fixed-Dose Combination Therapy to Treat Patients with Type 2 Diabetes
Date:12/12/2012

RARITAN, N.J., Dec. 12, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) today announced it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for a fixed-dose therapy combining canagliflozin and immediate release metformin to treat patients with type 2 diabetes.

Canagliflozin is an investigational, oral medication for the treatment of adult patients with type 2 diabetes. The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to people without diabetes, which may contribute to elevated glucose levels. Canagliflozin, a selective sodium glucose co-transporter 2 (SGLT2) inhibitor, blocks the reabsorption of glucose by the kidney, increasing glucose excretion and lowering blood glucose levels.

Metformin is a first-line pharmacotherapy that can be used alone or with other medications, including insulin, to treat type 2 diabetes. In people with type 2 diabetes, the liver overproduces glucose, which increases blood glucose levels. Metformin lowers blood glucose levels by decreasing the amount of glucose made by the liver.

If approved, this canagliflozin/metformin fixed-dose combination therapy could provide convenience for patients who may benefit from two diabetes medications working in one pill.

A significant portion of the clinical data in this NDA are derived from the comprehensive global Phase 3 clinical development program for canagliflozin, which were included in the NDA submitted to the FDA on May 31, 2012. The canagliflozin Phase 3 program represents the largest late-stage development program for an investigational pharmacologic product for the treatment of patients with type 2 diabetes submitted to health authorities to date.

The Phase 3 program evaluated the safety and efficacy of canagliflozin across the sp
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SOURCE Janssen Research & Development, LLC
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