Spherix Global Insights

December 01, 2021

Renal Anemia Market Revs Up in Europe With the Launch of FibroGen Inc’s/Astellas Pharma’s EVRENZO (Roxadustat), Spherix Global Insights Reports

Recent survey of 255 nephrologists in clinical practice in France, Germany, Italy, Spain, and the UK reveals EVRENZO offers the opportunity to improve anemia outcomes, particularly among non-dialysis patients with chronic kidney disease (CKD)

EXTON, Pa., / December 1, 2021 / PRNewswire – For decades, nephrologists across the globe have prescribed erythropoietin stimulating agents (ESAs), such as Amgen’s Aranesp, Roche’s Mircera, and a host of branded and biosimilar epoetin agents to manage anemia of CKD in dialysis and non-dialysis patients. While effective at increasing hemoglobin, there have been safety concerns associated with the use of ESAs and, particularly for non-dialysis patients, the need for IV or subcutaneous administration can be a barrier to patient acceptance.

In mid-August, the European Medicines Association (EMA) approved FibroGen Inc’s/Astellas Pharma’s EVRENZO (roxadustat) for the treatment of symptomatic anemia in patients with CKD, the first oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHi) approved in the region.

Overall, about one in five EU nephrologists surveyed by Spherix in October 2021 have trialed at least one patient on EVRENZO, with early trial rates strongest in Germany and Spain. For patients on dialysis, nephrologists see the brand filling the unmet need for efficacy amongst ESA hypo-responders; while in the non-dialysis setting, the convenience of an oral alternative to ESAs is the greatest unmet need EVRENZO is expected to fill.

Indeed, according to the inaugural report included in Spherix’s RealTime Dynamix™: Renal Anemia (EU5) service, the majority of surveyed nephrologists agree that HIF-PH inhibitors represent a more physiologic way of treating anemia compared to ESAs. However, a similar percentage admit that they are more comfortable with the risks that exist with ESAs than they are with the unknown side effects that may exist with HIF-PHIs.

In fact, it was concern about safety that sidelined roxadustat in the United States. With FDA approval originally anticipated in December 2020, FibroGen and AstraZeneca endured one setback after another, ultimately receiving a Complete Response Letter (CRL) in August 2021 stating that an additional clinical study would be required prior to resubmission.

This opens the door for Akebia Therapeutics with in-class challenger vadadustat, which has a PDUFA date set for March 2022, as well as GSK with daprodustat, which recently showcased favorable Phase 3 data at the American Society of Nephrology meeting in November. Despite the negative news surrounding the roxadustat CRL, US nephrologists remain bullish about the class, according to the most recent RealTime Dynamix: Renal Anemia (US) survey. The majority of those surveyed would have preferred that roxadustat be approved with either a warning or black box in the label.

While EU nephrologists anticipate strong share performance and an expanded user base for EVRENZO in the next six months, ESAs are likely to continue to dominate, particularly in the dialysis setting. In non-dialysis, over 40% of nephrologists intend to prescribe EVRENZO before ESAs, which could disproportionately impact Amgen’s Aranesp, which is preferred by the majority of EU nephrologists for anemia treatment in the CKD non-dialysis setting.

Indeed, when asked which anemia treatment they would personally choose for themselves, close to one-half of EU respondents chose a HIF-PH inhibitor for treatment in non-dialysis. About one-quarter selected a HIF-PH inhibitor for the dialysis setting suggesting that, outside of the group of ESA hypo-responders, EVRENZO uptake in dialysis may come at a slower pace.

The EU survey also explored attitudes about the use of oral and IV iron and revealed further differences between US and EU nephrologists regarding target ferritin levels and approach to IV iron use in the dialysis setting. About one-third of EU respondents note that minimizing the need for IV iron among hemodialysis patients could be another potential benefit to EVRENZO, as nearly one-half feel that iron overload is a growing concern in hemodialysis patients.

The next wave of the US survey will be released this month and the next fielding of the EU survey will take place in April 2022. To learn more about Spherix’s coverage of the renal anemia market, please visit our website.

 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 primary research and our in-house team of experts.

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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.

All company, brand or product names in this document are trademarks of their respective holders.

Citations:

1Roxadustat is approved in EU member states, including the EEA countries, as well as in Japan, China, Chile and South Korea for the treatment of anemia of CKD in adult patients on dialysis (DD) and not on dialysis (NDD). Astellas and FibroGen are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia of CKD in territories including Japan, Europe, Turkey, Russia and the Commonwealth of Independent States, the Middle East, and South Africa. FibroGen and AstraZeneca are collaborating on the development and commercialization of roxadustat for the potential treatment of anemia of CKD in the U.S., China, other markets in the Americas, in Australia/New Zealand, and Southeast Asia. Source: https://www.globenewswire.com/news-release/2021/08/19/2283933/33525/en/Astellas-Receives-European-Commission-Approval-for-First-in-Class-EVRENZO-roxadustat-for-Adult-Patients-with-Symptomatic-Anemia-of-Chronic-Kidney-Disease.html