FDA, Farxiga, Type 1

FDA Does Not Approve Farxiga for Type 1

The U.S. FDA did not approve AstraZeneca’s drug Farxiga (dapagliflozin) for use in type 1 diabetes. AstraZeneca was seeking approval for the drug to be used as a supplemental medication for type 1 when insulin alone is not regulating blood sugar. 

Farxiga has already been approved for type 2, and brought in $1.39 billion in sales in 2018 alone. It is known to help with blood sugar control, weight loss, cardiovascular health, and blood pressure. 

The drug was already approved in Europe (5 mg) and Japan (5 mg) under the name Forxiga to be used as a supplement to insulin in type 1 patients. 

It is not known why the FDA rejected the drug, but it could have something to do with the risk of diabetic ketoacidosis. For this reason, Farxiga is only approved in Europe and Japan in people with a BMI over 27. 

Explaining type 1

In type 1 diabetes, the body attacks the beta cells of the pancreas that produce insulin. Insulin is an essential hormone that the body uses to convert sugar to energy. Type 1 is a chronic condition in which people have to take insulin all of their lives, either via injections or an insulin pump.   


How Farxiga works

In the past, injectable insulin was the only way to treat type 1 diabetes. With the addition of this oral once-a-day pill, people who can’t get their blood sugar levels under control could be more successful at managing their diabetes.

Farxiga is part of a group of drugs called SGLT2 inhibitors. These medications work in the kidneys by helping to release glucose through the urine when blood sugar levels get too high. Other drugs in this class are Jardiance and Invokana.  

In order to use Farxiga, patients have to first pass certain requirements and not have a BMI below 27 kg/m². The medication is not recommended for those with low insulin requirement or those who are on dialysis.

Possible side effects of Farxiga

Side effects of Farxiga could include:

  • Dehydration
  • Diabetic ketoacidosis
  • Kidney problems
  • Yeast infections
  • Bacterial infections in the genitals
  • Urinary tract infections
  • Low blood sugar
  • Increase in bad cholesterol
  • Stuffy/runny nose
  • Sore throat
  • Changes in urination patterns
  • Bladder cancer

AstraZeneca will initiate discussions with the FDA on the next steps to get the drug approved. Note that there have been reports of complications when using SGLT2 inhibitors. Talk with your doctor about the benefits and side effects of Farxiga for diabetes.