FDA Approves Oral Tablets for Anemia Due To Chronic Kidney Disease

On Wednesday, the FDA approved the first oral treatment for anemia caused by chronic kidney disease.

Key takeaways:

The drug produced by GlaxoSmithKline LLC., Jesduvroq (daprodustat), is a once-a-day treatment for anemia caused by chronic kidney disease in adults who have been receiving dialysis for at least four months.

Adults who have not been receiving dialysis for at least four months are not eligible for Jesduvroq. Dialysis is a treatment for individuals who are struggling with kidney failure by assisting in the removal of waste along with excess fluid from the blood.

Anemia is a condition when the blood has low levels of red blood cells or hemoglobin. Hemoglobin is a rich protein that helps red blood cells carry oxygen from the lungs to the entire body. Low amounts of hemoglobin result in vital tissues and organs not receiving sufficient oxygen.

Symptoms of anemia can vary, and in some instances may not be present. However, some signs of anemia may occur.

These symptoms include:

  • Fatigue
  • Weakness
  • Pale or yellow-colored skin
  • Irregular heartbeats
  • Dizziness or lightheadedness
  • Chest discomfort
  • Cold hands and feet
  • Headaches

Anemia can also be a complication of chronic kidney disease. The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) says one out of seven people with kidney disease have anemia.

Ann Farrell, M.D., is the director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. She emphasizes the significance of new treatments for patients suffering from chronic kidney disease on dialysis in an FDA release.

"With an oral drug option in addition to the FDA-approved injection options, adults with chronic kidney disease on dialysis now have multiple ways to treat their anemia," Farrell said. "This approval demonstrates the FDA’s commitment to helping bring a range of therapeutic options to patients with chronic diseases. Patients can consult with their healthcare providers to select the option that is most appropriate."

The FDA highlights multiple possible side effects of Jesduvroq. The newly-approved drug contains a boxed warning for a raised risk of thrombotic vascular (blood clotting) events including death, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site.

Also, the FDA says Jesduvroq has warnings for higher chances of hospitalization due to heart failure, increased blood pressure, and stomach erosions along with gastrointestinal bleeding.

What is chronic kidney disease?

Chronic kidney disease is the gradual loss of kidney function. Kidneys serve as filters for waste and excess fluid from the blood that are released in urine. Advanced chronic kidney disease can also result in a higher likelihood of obtaining anemia.

Risk factors associated with chronic kidney disease include diabetes, high blood pressure, heart disease, smoking, obesity, and a family history of the disease.

The CDC says kidney diseases are a leading cause of death in the U.S. Currently, 40% of Americans with reduced kidney function are not aware of their chronic kidney disease.

Ways to avoid chronic kidney disease

The CDC recommends keeping blood pressure below 140/90 mm Hg, or the number discussed with a doctor. For those with diabetes, the CDC recommends staying in the recommended targeted blood sugar range.

Smoking can worsen the effects of kidney disease and interrupt medication that lowers blood pressure. Over 16 million Americans die from a smoking-related disease each year, with chronic kidney disease being one of the culprits.

Also, the CDC recommends losing weight if you are obese to reduce the risk of chronic kidney disease. According to the CDC, obesity prevalence in the U.S. between 2017 and 2020 was 41.9%.

Physical activity is recommended as a way to combat obesity, but can also help control blood pressure and blood sugar levels. The U.S. Department of Health notes increased health benefits when adults push the 300 minutes per week of moderate-intensity workouts.

Moderate-intense activities include brisk walking, recreational swimming or water aerobics, and yoga. At the minimum, the U.S. Surgeon General recommends for adults 150 minutes of exercise per week and 60 minutes of play per day for children.

Healthy eating habits can also play a role in helping combat obesity. Removing comfort food and sugar-sweetened beverages will help against added calories with little nutritional benefit. Nutritious meals should consist of healthy servings of fruits and vegetables and lean meats as opposed to processed meats.

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