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FDA Approves GSK's Drug For Anemia Caused By CKD For Adults On Dialysis

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The U.S. Food and Drug Administration approved GlaxoSmithKline LLC's Jesduvroq tablets (daprodustat) for anemia caused by chronic kidney disease or CKD for adults who have been receiving dialysis for at least four months.

It is the first oral treatment for anemia, i.e., decreased number of red blood cells, in the given indication that has received FDA approval. Other FDA-approved treatments for this condition are injected into the blood or under the skin.

Meanwhile, Jesduvroq is not approved for patients with anemia due to CKD who are not on dialysis because its safety has not been established in that population.

In the U.S., more than a half million adults have CKD requiring dialysis. In a person with chronic kidney disease on dialysis, the kidneys cannot produce enough erythropoietin, leading to reduced numbers of red blood cells.

The FDA noted that Jesduvroq increases erythropoietin levels. The drug's effectiveness was established in a randomized study of 2,964 adults receiving dialysis.

In this study, adults received either oral Jesduvroq or injected recombinant human erythropoietin, and Jesduvroq raised and maintained the hemoglobin within the target range of 10-11 grams/deciliter, similar to that of the recombinant human erythropoietin.

Ann Farrell, director of the Division of Non-Malignant Hematology in the FDA's Center for Drug Evaluation and Research, said, "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."

The most common side effects of Jesduvroq include high blood pressure, thrombotic vascular events, abdominal pain, dizziness and allergic reactions.

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