The Food and Drug Administration has approved Jesduvroq tablets (daprodustat), the first oral treatment for renal disease-related anemia in adults who have been on dialysis for four months or more, the agency announced Wednesday.
Chronic kidney disease can lead to a decreased number of red blood cells, or anemia. The newly approved Jesduvroq increases levels of the hormone erythropoietin, which helps to raise red blood cell production.
Oral delivery option
A key benefit of Jesduvroq is its oral delivery, the FDA stated. The two other treatments available for these patients are administered via venous injection or subcutaneously (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, of the FDA’s Center for Drug Evaluation and Research, in a statement.
Side effects associated with Jesduvroq include high blood pressure, thrombotic vascular events, abdominal pain, dizziness and allergic reactions, the FDA noted. The drug is contraindicated for patients with uncontrolled high blood pressure. It is not approved for patients who are not on dialysis.
A boxed warning includes increased risk for blood clotting-related events, among other warnings and precautions.
Study results
Jesduvroq was evaluated in a randomized study of 2,964 adults receiving dialysis. Patients administered either Jesduvroq or the standard of care, injected recombinant human erythropoietin. Jesduvroq raised and maintained hemoglobin (a measure of anemia) within a target range that was comparable to the injected treatment.
LTC stats
Chronic kidney disease that requires dialysis is found in more than a half million U.S. adults, according to the FDA. A 2021 study found that in the year preceding death, over one-third of Medicare beneficiaries on dialysis resided in a skilled nursing facility.
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