The FDA has indicated that it will not approve roxadustat for the treatment of anemia in chronic kidney disease (CKD) patients without more data to work with.
The medication, an oral HIF-PH inhibitor designed to improve red blood cell production and improve iron absorption, is manufactured by FibroGen and AstraZeneca.
Roxadustat has already been approved to treat CKD-related anemia in other parts of the world, including China, Japan, Chile and South Korea. Before the FDA can approve its use, however, the agency is requesting that an additional clinical study be conducted on non-dialysis dependent and dialysis-dependent patient populations.
“We are deeply disappointed with this result, and this is an unfortunate day for patients suffering from anemia of CKD in the United States,” Enrique Conterno, CEO of FibroGen, said in a prepared statement. “Roxadustat is changing the lives of patients around the world, and we and our partner AstraZeneca will discuss next steps in the U.S.”
In its own statement about the news, AstraZeneca emphasized that the medication’s safety and efficacy have already been demonstrated in five different peer-reviewed journal articles.
Michael has more than 16 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.