Roxadustat
Roxadustat, sold under the brand name Evrenzo, is an anti-anemia medication. Roxadustat is a HIF prolyl-hydroxylase inhibitor that increases endogenous production of erythropoietin and stimulates production of hemoglobin and red blood cells. It was investigated in clinical trials for the treatment of anemia caused by chronic kidney disease. It is taken by mouth. The drug was developed by FibroGen, in partnership with AstraZeneca.
The most common side effects include hypertension, vascular access thrombosis, diarrhea, peripheral edema, hyperkalemia and nausea.
Roxadustat received its first global approval in China in December 2018, for the treatment of anemia caused by chronic kidney disease in people who are dialysis-dependent. It was approved in Japan in 2019, for the treatment of anemia caused by chronic kidney disease in people on dialysis, and in 2020 for people not on dialysis. Roxadustat was approved for medical use in the European Union in August 2021.
Medical uses
Roxadustat is indicated for treatment of adults with symptomatic anemia associated with chronic kidney disease.
Adverse effects
Roxadustat is reported to increase VEGF, a signal protein that can activate tumor growth and also is considered to cause pulmonary hypertension. In phase 3 trial conducted at 29 sites in China, roxadustat treatment was found to cause hyperkalemia, i.e., increase in serum potassium, and metabolic acidosis in patients.
Society and culture
Legal status
In July 2021, the Cardiovascular and Renal Drugs Advisory Committee of the US Food and Drug Administration voted against the use of roxadustat in people with anemia in chronic kidney disease, both for those that are non-dialysis-dependent and those that are on dialysis. Significant safety concerns were raised that the panelists believed could not be addressed without further study. Notably, prior to the vote of the FDA committee, FibroGen and AstraZeneca announced that the company had changed parameters used to analyze cardiovascular safety data, which made the drug appear safer than it is.
Usage as a doping product
Due to the potential applications of roxadustat in athletic doping, such as raising haemoglobin levels and stimulating the production of red blood cells, it has been incorporated into screens for performance-enhancing drugs, as it has already been detected being used illicitly by athletes. In March 2024, following a lengthy process, former world No. 1 tennis player Simona Halep received a nine month ban for unintentional use of roxadustat that was sourced to a contaminated supplement that she had ingested.