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 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.
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