UK agency approves roxadustat for anemia management in CKD
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The National Institute for Health and Care Excellence has recommended Evrenzo (roxadustat) as an option for treating anemia associated with chronic kidney disease in adults with stage 3 to 5 CKD with no iron deficiency.
Evrenzo is the first hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor to be recommended by the National Institute for Health and Care Excellence (NICE), according to a press release from Astellas Pharma Ltd. The company said the recommendation means “roxadustat will be available as an alternative to erythropoietin stimulating agents (ESAs) for patients who are not on dialysis at the time of starting treatment (with no requirement to stop should they start dialysis).”
Roxadustat is also in phase 3 clinical trials development for anemia associated with myelodysplastic syndromes and phase 2 for chemotherapy-induced anemia, the company said.
Astellas presented data in May at the 59th European Renal Association Congress showing no evidence of an increased risk of cardiovascular events or mortality with roxadustat compared with ESAs in patients with symptomatic anemia associated with CKD who are non-dialysis-dependent and incident dialysis-dependent. Data drawn from four phase 3 studies evaluating the safety and efficacy of Evrenzo “showed no evidence of an increased risk of cardiovascular events or mortality with roxadustat compared with standard of care, ESAs,” Astellas said in a press release.
Roxadustat was noninferior to ESAs for risk of a major adverse cardiovascular event (MACE) and a major adverse cardiovascular event plus congestive heart failure or unstable angina requiring hospitalization (MACE+) with a consistent finding for all-cause mortality (ACM), according to the release.
“I’ve seen first-hand the effect anemia can have on those living with CKD, and it impacts almost every aspect of their daily lives,” Jonathan Barratt, PhD, FRCP, consultant nephrologist at University of Leicester, United Kingdom, said. “I’m pleased to present these data which demonstrate that, as an alternative oral treatment that controls anemia with a reduced need for IV iron compared to standard of care, roxadustat has the potential to alleviate the burden many living with this condition have — with no risk of increase in cardiovascular events or mortality when compared with the existing standard of care,” he said in the release.
Roxadustat is approved in the United Kingdom, as well as in Japan, China, Chile and South Korea for the treatment of anemia associated with CKD in adult patients on dialysis and not on dialysis. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia associated with CKD in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East and South Africa, according to the release.
“‘Most people do not realize the impact anemia can have on a person’s life,” Andrea Brown, CEO for the National Kidney Federation in the U.K., said. “A new treatment is important for those who do not tolerate current therapies and as a means of simplifying treatment for thousands of adults with anemia associated with CKD.”
The final appraisal document from NICE, which will undergo internal review through June 23, was based on results from a phase 3 clinical study (DOLOMITES), a randomized open-label, active controlled study comparing roxadustat to an ESA (darbepoetin alfa) in patients with non-dialysis dependent CKD with anemia.
References:
- Astellas analysis shows no evidence of increased risk of cardiovascular events or mortality with roxadustat compared with erythropoiesis-stimulating agents (ESAs). www.astellas.com/en/news/25831. Published May 19, 2022. Accessed June 16, 2022.
- Roxadustat for treating anemia in people with chronic kidney disease [ID1483] www.nice.org.uk/guidance/gid-ta10610/documents/html-content-3. Published June 13, 2022. Accessed June 16, 2022.
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