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Janssen gets FDA green light for new Invokana indication

Janssen Pharmaceuticals has received the Food and Drug Administration’s clearance for Invokana (canagliflozin) to reduce the risk of major adverse cardiovascular, or CV, events including heart attack, stroke or death due to a cardiovascular cause in adults with Type 2 diabetes who have established CV disease.

Invokana is the first and only oral diabetes treatment approved with this indication, according to the company.

"This FDA approval makes Invokana the only oral Type 2 diabetes treatment indicated to reduce the risk of heart attack, stroke or CV death. It is an important step forward for patients and the physicians who treat them," Janssen's research and development global therapeutic area head of cardiovascular and metabolism, James List, said. "Not only does Invokana enable patients to control their diabetes symptoms by lowering their A1C levels, but it now also helps protect them from potentially devastating cardiovascular events."

The new indication also applies to the fixed-dose combinations of Invokamet (canagliflozin/metformin HCl) tablets and Invokamet XR (canagliflozin/metformin HCl extended-release) tablets.

Invokana was first approved by the FDA on March 29, 2013 as an adjunct to diet and exercise to improve glycemic control in adults with T2D. Janssen Pharmaceuticals and its affiliates have rights to canagliflozin through a license agreement with Mitsubishi Tanabe Pharma Corporation, including in the United States.
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