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FibroGen/Astellas’ EVRENZO (roxadustat) Making In-Roads in European Market as In-Class Challenger, Akebia/Medice’s VAFSEO (vadadustat), Prepares for Launch in Early 2024.

EVRENZO’s advantages of being first-to-market and possessing a broader label are likely to be key factors influencing VAFSEO uptake, according to the latest update from Spherix Global Insights.

[Exton, PA., December 8, 2023]– EVRENZO made history as the initial hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) to receive EU approval in August 2021, securing its position by effectively catering to both dialysis and non-dialysis patient populations. In April 2023, Akebia Therapeutics’ VAFSEO, set to be marketed by Medice Arzneimittel Pütter GmbH & Co., gained European Commission approval, although its use was specified for dialysis-dependent patients alone. Meanwhile, GSK, the marketer of the sole approved HIF-PHI in the US, withdrew its application in July 2023, opting against introducing JESDUVROQ into the European market.

In the fifth bi-annual wave of tracking conducted by Spherix, 204 nephrologists across Germany, France, Italy, Spain, and the United Kingdom were surveyed regarding their present and future approaches to treating renal anemia in both dialysis-dependent and non-dialysis dependent patients. The analysis uncovered a noteworthy trend: while EVRENZO has been slow to gain traction, an overwhelming majority of surveyed nephrologists expressed intentions to significantly increase their utilization of the medication in the coming three months, signaling an anticipated near-doubling of its current market share. Particularly in the German market, nearly all nephrologists report that they have already begun gaining clinical experience with EVRENZO, with notably high levels of satisfaction.

When considering dialysis modality, a greater proportion of patients undergoing peritoneal dialysis who are using EVRENZO were found to have no prior exposure to ESAs (erythropoiesis-stimulating agents) in comparison to those undergoing hemodialysis, although this discrepancy varies by EU country. The Q4 2023 findings demonstrated substantial market share increases across both dialysis modalities for EVRENZO, marking a noteworthy uptick compared to previous quarters.

The utilization of EVRENZO among non-dialysis patients has grown across various stages, encompassing Stage 3, Stage 4, and Stage 5 patients. This increase aligns with a growing consensus of agreement with the statement: “My treatment of anemia in non-dialysis patients will increase now that EVRENZO is available”.  Impressively, over 70% of respondents concur that the advantages of EVRENZO outweigh the associated risks in this population, with a prevailing belief that this patient group stands to gain the most benefit from the drug. Like its reception in the dialysis setting, there’s a positive forecast for increased non-dialysis utilization over the next six months across all surveyed countries.

Despite the uptake of EVRENZO, a consensus among most nephrologists persists that there remains a pressing demand for multiple HIF-PHIs. Anticipation runs high for Akebia/Medice’s forthcoming VAFSEO in the dialysis sector, which is set for an official near-term launch in 2024. Indeed, at least one-quarter of respondents express intentions to prescribe VAFSEO immediately upon its market entry.  Projections indicate that these two drugs will collectively impact the usage of ESAs, rather than competing head-to-head in the dialysis domain. Notably, EVRENZO holds a distinct advantage with its exclusive non-dialysis indication—a factor often seen as a precursor to its use in dialysis—potentially offering a competitive edge in the market.

Spherix Global Insights will continue to cover the evolving US and EU renal anemia markets via its RealTime Dynamix™ and Patient Chart Dynamix™ services:

RealTime Dynamix: Renal Anemia is an on-going, independent study conducted twice per year in the EU and quarterly in the US.  The study covers the use of ESAs, HIF-PHIs and IV iron in the dialysis and non-dialysis settings.

Patient Chart Dynamix: Renal Anemia is an annual, retrospective patient chart audit of dialysis and non-dialysis patients that analyzes treatment patterns, biochemical parameters, symptoms, co-morbidities, and the patient journey as it relates to the management of CKD anemia.

About Spherix Global Insights

Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company’s unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.

A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology, and ophthalmology.

To learn more about Spherix Global Insights, visit or connect through LinkedIn and Twitter.

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NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement by any company, brand, or product aforementioned.

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