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

More than a half million adults in the U.S. have chronic kidney disease requiring dialysis (a treatment that filters the blood and removes excess fluid from the blood). Kidneys produce a hormone called erythropoietin, which signals the body to make red blood cells. In a person with chronic kidney disease on dialysis, the kidneys cannot produce enough erythropoietin, leading to reduced numbers of red blood cells.

Jesduvroq increases erythropoietin levels. The effectiveness of Jesduvroq 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 (a standard of care treatment for patients with anemia due to chronic kidney disease). Jesduvroq raised and maintained the hemoglobin (the protein in red blood cells that carries oxygen and is a common measure of anemia) within the target range of 10-11 grams/deciliter, similar to that of the recombinant human erythropoietin.

Jesduvroq has a boxed warning for an increased risk of thrombotic vascular (blood clotting) events including death, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site. Jesduvroq's warnings and precautions include a risk of hospitalization for heart failure, worsening increase of blood pressure, and stomach erosions and gastrointestinal bleeding.

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

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

Patients should not use Jesduvroq if they also take certain drugs that cause increased levels of Jesduvroq or if they have uncontrolled high blood pressure.

The FDA granted the approval to GlaxoSmithKline LLC.