Janssen Research & Development, LLC 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 spectrum of type 2 diabetes and included placebo- and active comparator-controlled studies. The program also includes a study in patients who have or are at high risk for developing cardiovascular disease, called the CANagliflozin cardioVascular Assessment Study (CANVAS).
Janssen presented data from Phase 3 studies at the American Diabetes Association (ADA) in Philadelphia in June, at the European Association for the Study of Diabetes (EASD) in Berlin in October, and at the World Congress on Controversies to Consensus in Diabetes, Obesity, and Hypertension (CODHy) in Barcelona in November.
Janssen and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation. Janssen Pharmaceuticals, Inc. has marketing rights in North America, South America, Europe, the Middle East, Africa, Australia, New Zealand and parts of Asia.
About Type 2 Diabetes
Type 2 diabetes is a chronic condition that affects the body's ability to metabolize sugar, or glucose, and is characterized by the inability of pancreatic beta cell function to keep up with the body's demand for insulin. People with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to non-diabetic people, which may contribute to elevated glucose levels. In most people with type 2 diabetes, obesity causes resistance of the body to the action of insulin and if the pancreatic beta cell cannot produce enough insulin, hyperglycemia and type 2 diabetes ensue.
If left uncontrolled, type 2 diabetes can lead to serious long-term microvascular complications such as nerve disease leading to amputation, retinopathy resulting in blindness and nephropathy causing end-stage renal disease. Improved glycemic control has been demonstrated to reduce the onset and progression of these complications.
About Janssen Research & Development, LLC
Janssen Research & Development, LLC is headquartered in Raritan, N.J. and has affiliated facilities in Europe, the United States and Asia. Janssen Research & Development is leveraging a combination of internal and external innovation to discover and develop novel medicines and solutions in five distinct therapeutic areas: Neuroscience, Oncology, Immunology, Infectious Diseases and Vaccines, and Cardiovascular and Metabolism. For more information about Janssen Research & Development, LLC visit www.janssenrnd.com .
Janssen Research & Development is part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Driven by our commitment to patients, we work together to bring innovative ideas, products, services and solutions to address serious unmet medical needs around the world.
Source: Janssen Research & Development LLC