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Monday, April 1, 2013 - Page updated at 09:00 p.m.
FDA approves new drug to treat type 2 diabetes
By ANDREW POLLACKKATIE THOMAS
The New York Times
The Food and Drug Administration (FDA) has approved the first of a new class of medicines to treat diabetes.
The drug, Invokana, will be sold by Johnson & Johnson and will be used to treat some patients with type 2 diabetes in a new way, by causing blood sugar to be excreted in the urine. Many existing drugs work by affecting the supply or use of insulin.
Invokana, approved Friday, will have a wholesale price of $8.77 a tablet, with one tablet taken daily. Clinical trials of more than 10,000 patients showed Invokana improved patients’ blood-sugar levels and led to weight loss and reductions in blood pressure.
But the drug, whose generic name is canagliflozin, also has potentially serious side effects. The clinical trials revealed signs of elevated stroke risk and a small increase in patients experiencing heart attacks within the first 30 days of taking the medicine.
The drug also was shown to raise LDL, or “bad” cholesterol levels, although it also raised the level of HDL, or “good” cholesterol. The drug is not recommended for patients with severe kidney disease.
The FDA is requiring Johnson & Johnson to conduct five post-marketing studies, including a clinical trial to more definitively determine if the drug increases the risk of heart attacks and strokes. Another study will monitor for cancers, pancreatitis and liver problems.
An estimated 26 million Americans have type 2 diabetes.