> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Raises Roxadustat Safety Concerns
- URL: https://www.fdaweb.com/fda-raises-roxadustat-safety-concerns/
- Published: 2021-07-13T12:00:00.000Z
- Updated: 2026-09-14T17:06:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149696

In a briefing document prepared in advance of a 7/15 meeting of the FDA Cardiovascular and Renal Drugs Advisory Committee to discuss the NDA for FibroGen’s roxadustat, the agency raises safety concerns for the committee to consider. The roxadustat proposed indication is to treat anemia due to chronic kidney disease in adult patients not on dialysis and on dialysis.

The [briefing document](https://www.fda.gov/media/150728/download?ref=fdaweb.com) says roxadustat’s efficacy is comparable to that of erythropoiesis stimulating agents (ESAs) that have the same indication. It also says there are important risks of serious thromboembolic events, as well as other risks, with roxadustat. “Both ESAs and roxadustat have pro-thrombotic events,” the document says. “This observation raises important questions for discussion. First, how should roxadustat’s risks be considered in the context of its benefits? Second, what are the causes of the thrombotic risk that is now observed across classes, and what are the contributing factors.”

The briefing document has six questions for committee members about the approvability of roxadustat in both the dialysis-dependent and non-dialysis-dependent patient populations.