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FDA Approves InvokanaTM for Type 2 Diabetes, Despite Heart Risk Concerns

Filed February 1st, 2013 admin

A U.S. Food and Drug Administration (FDA) panel has recommended that the agency approve the marketing of Johnson & Johnson’s (J&J) Type 2 diabetes drug, InvokanaTM (canagliflozin), despite the risks associated with the drug.

The recommendation, which was made by way of a 10-5 vote, comes after an earlier determination by a different FDA panel that the drug may increase the risk of cardiovascular problems, including raised cholesterol levels, diabeteshealth.com said. If the FDA follows the recommendation of the panel, the approval of InvokanaTM would be the first time that the class of drugs called SGLT2 (sodium glucose co-transporter 2) inhibitors will be offered on the U.S. market, diabeteshealth.com said. The drugs are believed to increase the amount of blood sugar that is excreted through urine.

J&J’s supporting data from a Phase 3 trial came from 10,285 patients enrolled in nine studies. That grouping was then divided into four criteria: Patients taking 100 mg and 300 mg daily doses of canagliflozin or placebo; older patients; patients with moderate kidney damage; and patients at risk for cardiovascular disease.

In Type 2 diabetes patients, the kidneys reabsorb significant amounts of glucose back into the body, compared to people who do not have the disease. Scientists suspect that this re-absorption is one of the reasons why Type 2 diabetic patients have higher blood sugar levels when compared to non-patients, diabeteshealth.com said. Since the new drug works on the kidneys, the agency panel recommended that patients with impaired kidney function not take the drug. In addition, extensive patient studies showed that canagliflozin increases the risk of urinary tract and genital area fungal infections caused by germs feeding on excreted blood sugar, diabeteshealth.com said.

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