FibroGen/Astellas' EVRENZO (roxadustat) Gaining Traction in the United Kingdom and Germany, according to Spherix Global Insights

Findings are based on a bi-annual study of 252 European Union & United Kingdom nephrologists

EXTON, Pa., Dec. 6, 2022 /PRNewswire/ -- After a regulatory debacle in the United States which ended with FibroGen and AstraZeneca receiving a Complete Response Letter in August 2021 for Roxadustat, FibroGen found success with partner Astellas in Europe.

EVRENZO was approved by the European Medicines Agency (EMA) in August 2021, making it the first hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor to be approved in the region. In July 2022, the companies scored another win by securing an endorsement by the United Kingdom's National Institute for Health and Care Excellence (NICE).

In January 2021, Spherix collaborated with 263 European nephrologists to conduct a chart audit of 1,283 patients with chronic kidney disease (CKD) who were not yet on dialysis and had an eGFR<60ml/min/1.73m^2. The study explored overall management of CKD patients including referral patterns and presentation at referral, annual touchpoints, comorbidities, medication burden, lab results and symptoms.

With regard to anemia specifically, about 25% of the patients were being treated with erythropoietin-stimulating agents (ESAs) – including Amgen's Aranesp, Roche's Mircera, and a wide range of biosimilars – with 9% having been previously exposed and discontinued from ESA therapy. Only a fraction of the patients were treated with EVRENZO, with the highest use in the United Kingdom and most use originating in ESA-naïve patients. Among patients not currently treated with ESAs, in nearly one-third of the patient cases, the nephrologist would choose EVRENZO over ESA therapy; fewer than one-in-five would preferentially choose to treat with an ESA. The study also found that a sizeable percentage of ESA-treated patients were not considered optimally managed and about two-thirds of all ESA-treated patients complained of fatigue at their most recent visit.

The most recent report – RealTime Dynamix: Renal Anemia in the EU and United Kingdom – based on a survey fielded in September 2022 with 258 nephrologists in the United Kingdom, Germany, France, Italy, and Spain, found that EVRENZO use continues to grow across all CKD stages. Nephrologists in the United Kingdom continue to be the most aggressive users of the drug, although the majority of nephrologists in Germany have started to prescribe the agent as well. Share projections suggest substantial opportunity to expand the EVRENZO footprint as survey respondents anticipate four to five times as many CKD non-dialysis patients on the drug within the next six months. Estimates for EVRENZO uptake in the hemodialysis setting is more reserved as one of the largest perceived benefits of EVRENZO – its oral formulation – is not a major unmet need in this setting. The feedback from this survey suggests that in the hemodialysis setting, uptake will be primarily limited to the ESA hypo-responder group, which is only a small portion of the patient population.

As a result of being the only HIF-PH inhibitor on the market, it is not surprising that EU nephrologists increasingly choose EVRENZO as the best-in-class brand; however, 40% still believe all HIF-PH inhibitors will be clinically interchangeable.

With Akebia's vadadustat and GSK's daprodustat awaiting EMA review in the first half of 2023, EVRENZO only has a few months left to establish itself as the better alternative to ESAs before competition within the HIF-PH inhibitor class heats up. While the FDA's decision against approving roxadustat in the United States drives caution around the product for about 40% of European Union nephrologists, an approval for GSK's daprodustat – the only HIF-PH inhibitor agent to get a positive nod from the FDA thus far – could shake up the market in a big way.

The next wave of the patient chart study will be published in March 2023 with the fourth wave of trending for RealTime Dynamix available in May 2023.

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.

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.

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 spherixglobalinsights.com or connect through LinkedIn and Twitter.

Spherix Global Insights Contacts:

Meghan Staudt
Insights Director, Nephrology
[email protected]

Scott Upham, Corporate Communications
[email protected]

SOURCE Spherix Global Insights