Exton, Pennsylvania, July 20, 2023 (GLOBE NEWSWIRE) -- Nephrologists have long awaited the approval of HIF-PH inhibitors for the treatment of anemia in their chronic kidney disease (CKD) patients. While several agents within the class have found success globally, the U.S. struggled to get even just one approval across the finish line.
That was until February 2023, when GSK announced that its HIF-PH inhibitor candidate, Jesduvroq® (daprodustat), was approved by the U.S. Food & Drug Administration (FDA) for the once daily treatment of anemia due to CKD in adults who have been receiving dialysis for at least four months. However, Jesduvroq’s approval did come with a black box warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.
Despite its first-in-class approval in the U.S., data collected from more than 100 US-based nephrologists in Spherix’s RealTime Dynamix™: Renal Anemia (US) service reveals that the market overall has been quiet since the FDA nod, with the vast majority of physicians still waiting to hear anything from their primary dialysis center about the availability of Jesduvroq. While GSK has indicated that Jesduvroq’s launch is expected to take place in the second half of 2023, surveyed nephrologists express diminishing excitement about the HIF-PH inhibitor class overall, and Jesduvroq specifically, while they wait. At the same time, their perceptions of ESAs as a treatment for renal anemia in dialysis patients have become increasingly favorable.
Of note, though, Akebia just completed an End of Dispute Type A meeting with the FDA to discuss the forthcoming resubmission of its NDA for vadadustat as a treatment for anemia in dialysis patients and plans to resubmit the NDA by the end of the third quarter of 2023. With potential competition on the horizon, GSK’s window of opportunity to solidify a launch strategy and capitalize on its first-to-market status in the U.S. may be closing in.
The dynamics of the renal anemia market are very different in the EU, where FibroGen/Astellas’ HIF-PH inhibitor, Evrenzo® (roxadustat), has been approved and on the market for over a year to treat adult patients with symptomatic anemia associated with CKD. Meanwhile, Akebia’s Vafseo® (vadadustat) was also just recently approved by the European Commission (EC) in April 2023, but with a narrower indication to treat symptomatic anemia associated with CKD in adults on chronic maintenance dialysis. Finally, GSK is awaiting a decision from the EC on the potential approval of daprodustat, which could potentially gain a dual indication for the treatment of both dialysis and CKD non-dialysis patients.
Audited CKD non-dialysis patient charts from Spherix’s RealWorld Dynamix™: CKD Non-Dialysis (EU5) service reveal that while use of Evrenzo remains low to date, the percentage of non-dialysis patients on therapy did increase year-over-year. Compared to ESAs, EU5 nephrologists appear to be initiating their CKD non-dialysis patients on Evrenzo slightly earlier in their CKD progression and at a higher hemoglobin level, on average, pointing to a slow but noticeable shift in their overall approach to anemia management. Furthermore, the majority of physicians reported that they are likely to switch their ESA-treated patients to Evrenzo, which could foster a competitive opportunity for other agents, such as daprodustat, to snag early patient share, assuming it is eventually approved and available.
Per Spherix’s latest RealTime Dynamix™: Renal Anemia (EU5) study, many EU5 nephrologists consider there to be a high need for multiple HIF-PH inhibitor products to be available to treat anemia in their CKD patients, indicating they are open to prescribing multiple brands. They also identify several key factors outside of their familiarity with the various agents as drivers of brand differentiation, which will be important and impactful in their prescribing decisions if and when multiple agents are available. Being that surveyed nephrologists across the region largely consider their CKD non-dialysis patients as the population for which HIF-PH inhibitors provide the most value, both Evrenzo and daprodustat, if approved with a dual indication, could have a competitive edge over Vafseo.
Spherix will begin tracking the launch of Jesduvroq on a monthly and quarterly basis in the second half of 2023 as part of its Launch Dynamix™ service. Assuming approval, Akebia’s launch of vadadustat will also be covered once commercially available and benchmarked against Jesduvroq at a similar time post-launch.
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.
About Launch Dynamix™
Launch Dynamix™ is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand.
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.
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