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.