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# Panel Mixed on GSK Anemia Drug Due to Safety
- URL: https://www.fdaweb.com/panel-mixed-on-gsk-anemia-drug-due-to-safety/
- Published: 2022-10-27T12:00:00.000Z
- Updated: 2026-09-14T18:04:33.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153068

FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 10/26 to recommend approval of GlaxoSmithKline’s (GSK) anemia drug daprodustat for use in treating chronic kidney disease (CKD) in adult patients on dialysis, but it did not support approval in those who are not on dialysis. Panel members voted 13-3 that the therapy’s benefits outweigh its risks for kidney disease patients who require dialysis, and in the non-dialysis CKD population the panel voted 11-5 against approval due to safety concerns.

In a [briefing document](https://www.fda.gov/media/162521/download?ref=fdaweb.com) released in advance of the meeting, FDA reviewers said the drug’s efficacy in raising hemoglobin levels was not in question, but they did raise safety issues both in patients on dialysis and not on dialysis. In the dialysis-dependent group in clinical trials, the document said, risks included hospitalization for heart failure and bleeding gastric erosions. In the non-dialysis-dependent patients, it appeared to have several additional risks, including elevated estimated risks for heart attack and stroke, and other potential issues.

Panel members voting against approval in non-dialysis patients suggested additional data would be necessary and showing a better safety profile than current data suggest. FDA is expected to make a review decision on or before the user fee review action target date of 2/1/2023.

GSK noted that oral daprodustat was developed to address an unmet need for convenient treatment options with efficacy and safety comparable to current intravenous treatments. It said the hypoxia-inducible factor prolyl hydroxylase inhibitor works by stabilizing “hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anaemia, similar to the physiological effects that occur in the human body at high altitude.”

Daprodustat is already approved in Japan for treating anemia in CKD patients, and it is currently under regulatory review by the European Medicines Agency.