FDA Approves Invokana, a New Type 2 Drug
A new, first-in-its-class drug for type 2 diabetes has just been approved by the Food and Drug Administration. Invokana works by blocking re-absorption of glucose by the kidneys and stimulating urination, which removes glucose from the bloodstream.
In the course of nine clinical trials that included over 10,000 patients, the drug improved both A1c and fasting glucose levels. In addition, the drug helps reduce weight and blood pressure. With a regimen that includes diet and exercise, the drug can be taken by itself or in combination with other drugs including insulin, metformin, and others.
Invokana is not intended for those with type1 diabetes, end-stage or severe kidney disease, or people undergoing dialysis. Additional FDA-mandated studies will investigate the drug’s effects on the heart, pancreas and other parts of the body; monitoring for malignancies, a bone safety study, and two studies in children.
Invokana, a tablet, is the first of a new class of drugs known as sodium-glucose co-transporter 2 (SGLT2) inhibitors. The most common side effects are vaginal yeast and urinary tract infections, thought to be caused by increased urination. As the drug encourages urination, it can also lead to a sudden fall in blood pressure when a patient stands, although this is most common in the first three months of therapy.
The drug is manufactured by Janssen Pharmaceuticals, part of Johnson & Johnson.