FDA Approves GSK’s Oral Drug for Chronic Kidney Disease-Related Anemia

The FDA has approved GSK’s Jesduvroq (daprodustat) for treatment of anemia due to chronic kidney disease and who have been receiving dialysis for at least four months.

Jesduvroq is the first oral treatment available — previous treatment approved by the agency are all injectables.

The FDA decision was supported by results from a phase 3 clinical trial in which Jesduvroq raised and maintained hemoglobin levels and was comparable to the standard-of-care treatment with recombinant human erythropoietin.

The drug comes with a boxed warning of increased risk of blood clotting events, including death, heart attack, stroke and blood clots in lungs, legs or dialysis access site.