The US Food and Drug Administration (FDA) has approved Jesduvroq tablets (daprodustat, GlaxoSmithKline) as the first oral treatment for anaemia caused by chronic kidney disease (CKD) for adults who have been receiving dialysis for at least four months. Jesduvroq is not approved for patients who are not on dialysis. Other FDA-approved treatments for this condition are injected into the blood or 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 anaemia,” said Ann Farrell of the Center for Drug Evaluation and Research at the FDA. “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 half a million adults in the USA have CKD requiring dialysis. 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 randomised 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 anaemia due to chronic kidney disease). Jesduvroq raised and maintained the haemoglobin within the target range of 10-11 grams/decilitre, similar to that of the recombinant human erythropoietin.
Jesduvroq has a boxed warning for an increased risk of thrombotic vascular 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 hospitalisation for heart failure, worsening increase of blood pressure, and stomach erosions and gastrointestinal bleeding.
Jesduvroq is not approved for patients with anaemia due to CKD 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.