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FDA alert

FDA Approves First Oral Treatment for CKD-Caused Anemia for Adults on Dialysis

Jessica Ganga
02/08/2023

The FDA has approved daprodustat (Jesduvroq) for the treatment of anemia caused by chronic kidney disease (CKD). The treatment is the first oral treatment for adults with CKD who have been receiving dialysis for at least 4 months. 

According to a press release by the FDA, more than a half million adults in the United States have CKD that requires treatment with dialysis. Anemia is a common adverse effect of dialysis, and other FDA-approved treatments for the side effect are injected into the blood or under the skin.

“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,” said Ann Farrell, MD., director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research, said in a press release. “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 approval follows a randomized study that examined the effectiveness of daprodustat. The study included 2964 adults with CKD who are receiving dialysis. Participants in the study received either oral daprodustat or injected recombinant human erythropoietin—the standard of care. The researchers found that daprodustat “raised and maintained the hemoglobin” within the study’s target range of 10 – 11 g/deciliter.

Daprodustat lacks approval for patients who are not receiving dialysis and comes with a warning for an increased risk of thrombotic vascular events, including heart attack, stroke, and death. Additionally, daprodustat may cause blood clots in the legs, lungs, or dialysis access site. Other warnings include a risk of hospitalization for heart failure, worsening increase of blood pressure, and stomach erosions and gastrointestinal bleeding.

Other adverse effects include abdominal pain, dizziness, and allergic reactions.

 

Reference:

FDA approves first oral treatment for amenia caused by chronic kidney disease for adults on dialysis. News release. US Food and Drug Administration; February 1, 2023. Accessed February 8, 2023. www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis