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# GSK’s Oral Anemia Drug Approved for Dialysis
- URL: https://www.fdaweb.com/gsks-oral-anemia-drug-approved-for-dialysis/
- Published: 2023-02-02T12:00:00.000Z
- Updated: 2026-09-14T18:14:27.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153693

FDA has approved a GlaxoSmithKline NDA for Jesduvroq (daprodustat) tablets that it describes as the first oral treatment for anemia caused by chronic kidney disease for adults who have been receiving dialysis for at least four months. The agency notes that the drug is not approved for patients who are not on dialysis, which appeared to follow a 10/22 advisory committee recommendation ([see story](https://www.fdaweb.com/panel-mixed-on-gsk-anemia-drug-due-to-safety/)). “With an oral drug option in addition to the FDA-approved injection options, adults with chronic kidney disease on dialysis now have multiple ways to treat their anemia,” an agency ease [release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis?ref=fdaweb.com) says.

Jesduvroq works by increasing erythropoietin levels. Its approval was based on data from a randomized [study](https://clinicaltrials.gov/ct2/show/NCT02879305?ref=fdaweb.com) of 2,964 dialysis adults who received either oral Jesduvroq or injected recombinant human erythropoietin, according to the agency. “Jesduvroq raised and maintained the hemoglobin (the protein in red blood cells that carries oxygen and is a common measure of anemia) within the target range of 10-11 grams/deciliter, similar to that of the recombinant human erythropoietin,” it says.

Addressing safety concerns raised during the advisory committee meeting, FDA says it is requiring Jesduvroq to have a Boxed Warning about increased thrombotic vascular events including death, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site. “Jesduvroq’s warnings and precautions include a risk of hospitalization for heart failure, worsening increase of blood pressure, and stomach erosions and gastrointestinal bleeding,” it says.

FDA also says the drug’s most common side effects include “high blood pressure, thrombotic vascular events, abdominal pain, dizziness and allergic reactions. Patients should not use Jesduvroq if they also take certain drugs that cause increased levels of Jesduvroq or if they have uncontrolled high blood pressure.”