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# Panel Shoots Down FibroGen’s Roxadustat
- URL: https://www.fdaweb.com/panel-shoots-down-fibrogens-roxadustat/
- Published: 2021-07-16T12:00:00.000Z
- Updated: 2026-09-14T17:06:40.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149728

FDA’s Cardiovascular and Renal Drugs Advisory Committee 7/15 overwhelmingly voted against recommending approval for a FibroGen NDA for roxadustat, indicated for treating anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis. Committee members agreed with an FDA [briefing document](https://www.fda.gov/media/150728/download?ref=fdaweb.com) citing risks of serious thromboembolic events, as well as other risks ([see earlier story](https://www.fdaweb.com/fda-raises-roxadustat-safety-concerns/)). The committee voted 13-1 against the approval for treatment of chronic kidney disease in patients not on dialysis and 12-2 against the approval for patients on dialysis.  

Roxadustat is an oral small molecule hypoxia-inducible factor prolyl hydroxylase inhibitor, according to the company. It is approved in China, Japan, Chile, and South Korea, and has received a positive opinion from the European Medicines Agency's Medicinal Products for Human Use Committee.