Daprodustat Receives FDA Approval for Anemia Caused by CKD on Dialysis

The US Food and Drug Administration (FDA) has announced the approval of daprodustat (Jesduvroq) for the treatment of anemia in patients with chronic kidney disease (CKD) who are on dialysis.¹

Announced in a statement on February 1, the approval, which is based on results of the ASCEND program, represents the first approval for an oral treatment for anemia caused by chronic kidney disease for adults who have been receiving dialysis for at least four months.

“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,” said Ann Farrell, MD, director of the Division of Non-Malignant Hematology in the FDA’s Center for Drug Evaluation and Research. “This approval demonstrates the FDA’s commitment to helping bring a range of therapeutic options to patients with chronic diseases. Patients can consult with their healthcare providers to select the option that is most appropriate.”

The subject of an October 2022 Cardiovascular and Renal Drugs Advisory Committee meeting, daprodustat received a 13-3 vote in favor of an indication for people with CKD on dialysis but received an 11-5 vote against an indication for the non-dialysis patient population.² As part of the aforementioned ASCEND program, GlaxoSmithKline’s oral hypoxia-inducible factor prolyl hydroxylase inhibitor was evaluated in multiple trials assessing in people with CKD. Results of the ASCEND-D trial, which included 2964 patients with CKD on dialysis, revealed daprodustat was noninferior to erythropoiesis-stimulating agents (ESAs) for the endpoint of change in hemoglobin level from baseline and in cardiovascular outcomes.³

“Anaemia of CKD can be a debilitating condition that is challenging to manage. This news means that patients on dialysis who are living with anaemia of CKD now have another treatment option to help manage their anaemia," said LaVarne Burton, President and Chief Executive Officer, American Kidney Fund, in a statement from GSK.⁴

In their release, the FDA noted daprodustat has a boxed warning risk of thrombotic vascular events including death, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site.¹ Additional warnings and precautions noted by the FDA included risk of hospitalization for heart failure, worsening increase of blood pressure, and stomach erosions and gastrointestinal bleeding. The FDA’s release also pointed out the most common side effects observed with daprodustat were high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions.¹

References

1. Commissioner Oof the. FDA approves first oral treatment for anemia caused by chronic kidney disease for adults on dialysis. U.S. Food and Drug Administration. https://www.fda.gov/news-events/press-announcements/fda-approves-first-oral-treatment-anemia-caused-chronic-kidney-disease-adults-dialysis. Published February 1, 2023. Accessed February 1, 2023.
2. Terry M. FDA Adcomm returns mixed vote on GSK's CKD drug - updated. BioSpace. https://www.biospace.com/article/fda-adcom-to-vote-on-gsk-s-drug-to-treat-chronic-kidney-disease/. Published October 27, 2022. Accessed February 1, 2023.
3. Singh AK, Carroll K, Perkovic V, et al. Daprodustat for the treatment of anemia in patients undergoing dialysis. New England Journal of Medicine. 2021;385(25):2325-2335. doi:10.1056/nejmoa2113379
4. Jesduvroq (daprodustat) approved by US FDA for anaemia of chronic kidney disease in adults on dialysis. GSK. https://www.gsk.com/en-gb/media/press-releases/jesduvroq-daprodustat-approved-by-us-fda-for-anaemia-of-chronic-kidney-disease-in-adults-on-dialysis/. Published February 1, 2023. Accessed February 1, 2023.