Spherix Global Insights

June 29, 2022

European Nephrologists Lead the Way with Adoption of Astellas/FibroGen’s HIF-PH inhibitor, EVRENZO (roxadustat), for Anemia of CKD Treatment in Both Dialysis and Non-Dialysis Settings

Recent endorsement of Evrenzo by the National Institute for Health and Care Excellence (NICE) could be a catalyst for further use as alternative to erythropoietin stimulating agents (ESAs)

EXTON, Pa., June 27, 2022 / PRNewswire / – The European regulatory authorities tend to be moving in a different direction than U.S. Food and Drug Administration (FDA) regarding novel HIF-PH inhibitor agents. Recent Spherix research provides insights from nephrologists across the EU5 regarding their view of the evolving anemia treatment landscape, including early use of first-in-class Evrenzo (roxadustat) and anticipated future use.

Spherix recently published the Q2 report included in their RealTime Dynamix™: Renal Anemia (EU5) service, which includes responses from 250 nephrologists in the EU5 (France, Italy, Germany, Spain, and the UK) surveyed between April 15 and May 19, 2022.

Nephrologists in the UK, Germany, and Spain stand out as leaders across the region in terms of their self-reported use of HIF-PH inhibitors in patients with anemia of CKD in both dialysis and non-dialysis settings. Compared to six months ago, EU5 nephrologists report the percentage of dialysis and CKD non-dialysis patients prescribed Evrenzo has at least doubled.

Importantly, EU5 nephrologists identified appropriate patient types and clinical considerations for using Evrenzo in both patient settings. CKD non-dialysis patients, and those who are specifically ESA naïve, are the most ideal candidates for Evrenzo, according to surveyed nephrologists. However, home dialysis and peritoneal dialysis patients also serve as an opportunity for increased use of the drug.

Regardless of CKD progression, some prescribers do face barriers to using Evrenzo. These include a lack of familiarity and experience with the drug, concerns about safety, and a perceived lack of clinical data (specifically long-term data) to support its use. Another barrier to prescribing Evrenzo lies around dialysis protocol restrictions, which are likely to be more influential in the UK and France versus Germany, Italy and Spain. However, looking ahead, most EU5 nephrologists who have not yet prescribed  Evrenzo intend to do so within the next six months.

Recently, the UK’s National Institute for Health and Care Excellence (NICE) recommended Evrenzo as an option for treating symptomatic anemia associated with CKD in patients in CKD Stages 3 to 5 with no iron deficiency, who are not on dialysis. The positive opinion from NICE supports Evrenzo’s use as a cost-effective oral treatment option for anemia.

Rapid adoption of EVRENZO will be critical for Astellas/FibroGen as competition looms from Otsuka/Akebia’s vadadustat and GSK’s daprodustat. Both drugs are currently under review by the European Medicines Agency (EMA).

Spherix will continue tracking uptake of the novel HIF-PHI class in the EU5 and the evolving pipeline in the US through its RealTime Dynamix™ service, which is supplemented with its recently released large-scale chart audit of 1,000 CKD non-dialysis patients in the EU5 in its RealWorld Dynamix: CKD Non-Dialysis (EU5) ™ service.

About RealTime Dynamix™
RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts.

About RealWorld Dynamix™
RealWorld Dynamix™ is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns.

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About Spherix Global Insights
Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence. We specialize in select immunology, nephrology, and neurology markets.

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