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FDA Panel Recommends J&J Diabetes Drug Canagliflozin - Quick Facts

Janssen Research & Development LLC, a subsidiary of Johnson & Johnson (JNJ), announced Thursday that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration or FDA voted 10-5 to recommend approval for canagliflozin, proposed trade name INVOKANA, to treat type 2 diabetes in adult patients based on the efficacy and safety results from its comprehensive clinical development program.

Canagliflozin is an investigational, oral, once-daily medication for the treatment of adult patients with type 2 diabetes. If approved by the FDA later this year, it would be the first in this new class of diabetes therapies available in the U.S., the company said.

The kidneys of people with type 2 diabetes reabsorb greater amounts of glucose back into the body compared to people who do not have 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 in people with diabetes who have elevated blood glucose levels.

The FDA will consider the advisory committee recommendation in its review of the New Drug Application (NDA) for canagliflozin that was submitted by Janssen on May 31, 2012, though the FDA is not bound to follow it.

the American Diabetes Association estimates that 26 million Americans have 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.

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