2023-02-02| Trials & Approvals

GSK’s Jesduvroq Wins FDA Approval for First Oral Drug for Anemia In Chronic Kidney Disease

by Joy Lin
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GlaxoSmithKline (GSK) has announced the US FDA approval for Jesduvroq tablets (daprodustat) in the treatment of anemia caused by chronic kidney disease in adults who have been on dialysis for at least four months. Patients who are not receiving dialysis are not eligible for the drug, as its safety has not been established in that population. 

Jesduvroq is the first oral treatment to be approved for this condition. Other FDA-approved alternatives are injected into the blood or under the skin. 

With the approval, adults with chronic kidney disease on dialysis now have multiple ways to treat their anemia, said Ann Farrell, M.D., director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. Over 500,000 adults in the US with chronic kidney disease require dialysis. 

“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,” said Farrell.

Jesduvroq was first approved in Japan in June 2022 as Duvroq tablets for renal anemia. In Europe, the European Medicines Agency (EMA) accepted the marketing authorization application for daprodustat in March 2022, and is currently reviewing the drug.   

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Jesduvroq Increases Erythropoietin Levels

The kidneys produce a hormone called erythropoietin, which tells the body to make red blood cells. People with chronic kidney disease on dialysis do not produce enough erythropoietin, which leads to anemia. 

Jesduvroq is a hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) that works by increasing erythropoietin levels. Its FDA approval is based on positive results from the Ascend Phase 3 clinical trial program, which included five pivotal studies examining Jesduvroq across varying degrees of chronic kidney disease. In one study, Jesduvroq raised and maintained hemoglobin levels within the target range of 10-11 grams/dL, similar to that of recombinant human erythropoietin, the standard of care for anemia in chronic kidney disease. 

While effective, Jesduvroq comes with a boxed warning for an increased risk of blood clotting events including heart attack and stroke. The drug may also increase the risk of hospitalization for heart failure, increase in blood pressure, and stomach erosions and bleeding in the gut. 

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