China First to Approve Oral Drug to Stimulate Erythropoiesis

China’s National Medical Products Administration approved the oral anemia drug roxadustat, well before regulators in the U.S. or Europe have issued decisions. The hypoxia-inducible factor prolyl-hydroxylase inhibitor mimics the body’s response to high altitude and is a convenient alternative to injectable blood enhancers.

The decision was based on results from an open-label, phase III trial comparing roxadustat with epoetin alfa in patients with dialysis-dependent anemia who were previously treated with various erythropoiesis-stimulating agents. The approval clears its use in patients with anemia caused by chronic kidney disease who are on dialysis.

Source: Reuters, December 18, 2018.