New Type of Diabetes Drug Approved by FDA

A Johnson & Johnson drug that treats type 2 diabetes in a new way is now approved by the U.S. Food and Drug Administration (FDA). Invokana, as the drug is known, will work by excreting blood sugar in the patient’s urine rather than affecting the supply or use of insulin.

This new type 2 diabetes drug falls in a class of medications called SGLT2 inhibitors. The drugs work by blocking action of the sodium-glucose co-transporter 2, which takes sugar removed from the blood by the kidneys and puts it back into the blood.

Prior to its approval, clinical trials with more than 10,000 patients revealed that Invokana improved blood sugar levels and led to lower blood pressure and weight loss. Among the estimated 26 million Americans with type 2 diabetes, many are prescribed medications that lead to weight gain and hypoglycemia, two dangerous health risks.

Clinical trials of Ivokana showed additional side effects that could be serious. These side effects include:

  • Raised LDL (bad) cholesterol levels
  • Vaginal yeast infections
  • Urinary tract infections
  • Elevated stroke risk
  • Small heart attack risk

The significance of the side effect findings remains unclear, according to the FDA. The label of Invokana includes no warnings about heart attack or stroke risk. However, the FDA requires Johnson & Johnson to conduct five post-marketing studies and one clinical trial to conclusively determine if the drug does increase risk of stroke and heart attack.

Despite possible serious side effects, Invokana is available to consumers at a wholesale price of $8.77 per tablet. Johnson & Johnson states the price of Invokana is competitive with other diabetic medications.

Read More about the FDA approval of Invokana  here.

Topics

PAST ARTICLES