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Anemia Treatment Receives FDA Approval

April 26, 2023

May 2023

The U.S. Food and Drug Administration (FDA) approved daprodustat tablets for the treatment of anemia in adults who have been receiving dialysis for chronic kidney disease for at least four months. It is the first oral treatment for anemia in these conditions. The treatment works by increasing erythropoietin levels.

Approval was based on the results of a randomized study, which found that compared to recombinant human erythropoietin, daprodustat was similarly effective at raising and maintaining hemoglobin levels.

The treatment has an increased risk of thrombotic vascular events such as blood clots in the legs, lungs, or dialysis access site; heart attack; stroke; and death. There is also a risk of stomach erosions, gastrointestinal bleeding, increases in blood pressure, and heart failure.

Common side effects of daprodustat include dizziness, abdominal pain, allergic reactions, high blood pressure, and thrombotic vascular events.

“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. “Patients can consult with their health care providers to select the option that is most appropriate.”

Source: FDA, February 1, 2023.

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