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The recommendation follows an earlier determination by another FDA panel that the drug may slightly increase the risk of cardiovascular problems, including raised cholesterol levels.
FDA approval of Invokana would mark the first time that the class of drugs called SGLT2 (sodium glucose co-transporter 2) inhibitors will be offered on the U.S. market. The drugs work by increasing the amount of blood sugar that is excreted through urine.
In type 2 diabetes patients, the kidneys reabsorb greater amounts of glucose back into the body than people who do not have the disease. Scientists suspect that this reabsorption is one of the reasons why type 2 patients have higher blood sugar levels than non-patients.
Because it works on the kidneys, the agency panel also recommended that patients with impaired kidney function not take the drug. Also, 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.
Johnson & Johnson's supporting data from a Phase 3 trial came from 10,285 patients enrolled in nine studies, which were divided according to several 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.
Besides risks identified with the drug, data showed that canagliflozin had positive effects on weight loss and blood pressure.
The FDA had previously investigated another experimental SLGT2 inhibitor, dapagliflozin, from Bristol-Myers Squibb Co. and AstraZeneca PLC. However, citing concerns about possible liver damage and elevated rates of bladder and breast cancer, the agency did not approve the drug.
The agency will decide by March 31 whether it will approve U.S. sales of Invokana.
0 comments - Feb 1, 2013