Roxadustat

Weighing the potential benefits for two different kidney patient populations, a review board for the FDA voted 13-3 to approve use of the anemia drug daprodustat for patients with dialysis-dependent chronic kidney disease.

The National Institute for Health and Care Excellence has recommended Evrenzo (roxadustat) as an option for treating anemia associated with chronic kidney disease in adults with stage 3 to 5 CKD with no iron deficiency.

I was disappointed that the recent decision by the Cardiovascular and Renal Drugs Advisory Committee of the FDA will further delay the availability of an orally administered agent for anemia treatment in patients with chronic kidney disease.

The FDA issued a complete response letter to FibroGen indicating it cannot approve the company’s new drug application that seeks approval of roxadustat for anemia of chronic kidney disease.