J&J’s Invokana becomes first FDA-approved oral diabetes drug to reduce cardiovascular event risk
pharmafile | October 31, 2018 | News story | Research and Development, Sales and Marketing | FDA, J&J, JJ, invokana, pharma
The FDA has given the go-ahead for Johnson & Johnson’s drug Invokana (canagliflozin) for use in the risk reduction of major adverse cardiovascular (CV) events, making it the “first and only oral diabetes treatment approved with this indication”, according to the manufacturer.
This means the therapy is now authorised for the treatment of heart attack, stroke or death due to a cardiovascular cause in adults with type 2 diabetes (T2D) who have established CV disease.
The decision was based on data derived from 10,000 type 2 diabetes patients, 65% of which had established CV disease and 35% of which were at risk of CV disease with two or more risk factors. It was found that, when combined with standard of care, Invokana reduced the combined risk of heart attack, stroke and CV death by 14% compared to placebo combined with standard of care. In patients with established CV disease, this figure rose to 18%.
“Americans living with type 2 diabetes are two to three times more likely to die from heart disease than adults without diabetes,” said Dr Ralph DeFronzo, Professor of Medicine and Chief of the Division of Diabetes at the University of Texas’ Health Diabetes Center. “With this approval, Invokana now plays an even more important role in the overall treatment mix with its demonstrated ability to reduce the risk of potentially devastating cardiovascular events.”
Dr James List, Global Therapeutic Area Head, Cardiovascular & Metabolism at Janssen Research & Development, also remarked: “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. 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.”
Matt Fellows
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