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# Roxadustat Restrictions Sought
- URL: https://www.fdaweb.com/roxadustat-restrictions-sought/
- Published: 2020-11-18T12:00:00.000Z
- Updated: 2026-09-14T16:36:52.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5148117

An 11/13 petition filed by Epstein Becker Green on behalf of an unnamed client asks FDA to require that adequate cardiovascular safety and all-cause mortality data be submitted to the agency for review before approving roxadustat for treating anemia in patients with chronic kidney disease. The [petition](https://www.regulations.gov/contentStreamer?documentId=FDA-2020-P-2193-0001&attachmentNumber=1&contentType=pdf&ref=fdaweb.com) also asks FDA to require a Boxed Warning in the drug’s labeling.

“Phase 3 clinical program data released by the roxadustat NDA applicant demonstrate that roxadustat poses an increased risk of adverse cardiovascular outcomes and mortality in comparison to the current standard of care, in particular, for patients who are stable on dialysis,” the petition says. “Moreover, data released to date fail to demonstrate that roxadustat provides a meaningful treatment benefit over the existing standard of care….”

The petition says FDA has required similarly situated applicants to provide additional evidence of safety when the applicant’s Phase 3 clinical program data, or post-marketing data, demonstrated the applicant’s product posed an increased risk of adverse cardiovascular outcomes and/or mortality in certain patient subpopulations.