U.S. Nephrologists Report Mixed Reactions to the Approval of GSK's Jesduvroq® (daprodustat) for the Treatment of Anemia in Dialysis Patients, According to Spherix Global Insights

09 Feb 2023
www.prnewswire.com
Drug Approval
110 U.S. nephrologists provided immediate feedback regarding GSK's newly approved HIF-PH inhibitor – the first approved in the United States – for the treatment of anemia in dialysis patients.
EXTON, Pa., Feb. 9, 2023 /PRNewswire/ -- Since 2017,
Spherix Global Insights has been monitoring the U.S. renal anemia market landscape, capturing nephrologists' perceptions and opinions of new therapies and management protocols. This heritage of renal market insight includes measuring nephrologists' evolving use of treatment options and their enthusiasm and projections for assets in the pipeline – most notably the oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) class.
On February 1, 2023, GSK announced that the US Food & Drug Administration (FDA)  approved
Jesduvroq® (daprodustat), a HIF-PHI, for the once daily treatment of anemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four (4) months. The Safety Information for Jesduvroq includes a Black Box warning for increased risk of death, myocardial infarction, stroke, venous thromboembolism, and thrombosis of vascular access.[1]
GSK filed the new drug application for uses in both CKD non-dialysis patients and in dialysis patients. Ultimately, Jesduvroq was only granted approval for dialysis patients unlike what has been seen for other HIF-PH inhibitors – including daprodustat – globally. Many nephrologists expressed frustration at this outcome, as they view the greatest value of oral HIF-PH inhibitors to be in CKD non-dialysis patients.
As part of its ongoing
RealTime Dynamix:
Anemia of CKD report series, Spherix Global Insights fielded a Pulse survey on February 2nd, 2023 to its proprietary network of U.S. nephrologists to collect immediate feedback on Jesduvroq's approval, label, and warnings.
Key initial findings from the Spherix study reveals that U.S. nephrologists are divided regarding their receptivity to the drug's recent approval. A portion of these nephrologists hold a bullish attitude and look forward to now having an additional option for patients.  Another subset of nephrologists took a more cautious approach and were disappointed with the limited utility of application based on the restrictive label.
A majority of physicians agreed with the FDA's decision to approve Jesduvroq with its Black Box warning that limits the drug's use to prevalent dialysis. This warning could possibly have an impact on prescribing projections.
When compared to pre-launch metrics, the overall timeline for drug adoption has been impacted.  This includes the average time to initiate a patient on Jesduvroq being extended. This extension will result in a slower and more deliberate adoption among nephrologists.
The requirement for patients to have been on dialysis at least four (4) months before initiating Jesduvroq therapy is likely to impact the overall product uptake. While some nephrologists said that the requirement did not matter, most indicated it would substantially impact use. The reasons included they will more often have to switch patients already established on ESAs instead of being able to start treatment naïve patients on therapy as would be the case with an incident dialysis patient indication.
Data from Spherix's
RealWorld Dynamix: Dialysis chart audit series, which includes chart data of more than 1,000 dialysis patients, further underpins the limitations that Jesduvroq's label requirements and Black Box warning will likely impose.  Specifically, Spherix analysts examined the potential pool of candidates and applied criteria outlined in the label and warnings that would disqualify candidacy.  By isolating and excluding those currently responding to ESA therapy (as many start therapy before starting dialysis or within the first few months of dialysis care) and those with known risk factors identified for Jesduvroq (i.e., cardiovascular disease, cancer, uncontrolled hypertension, etc.), Spherix ultimately uncovered that the overall candidate pool of potential Jesduvroq initiations has dropped precipitously.
Throughout the past few years of tracking the turbulent HIF-PH inhibitor market, including Complete Response Letters for both roxadustat (AstraZeneca/Fibrogen/Astellas) and vadadustat (Akebia), a consistent one-third of nephrologists appeared to be "HIF-supporters." Not surprisingly, approximately that same percentage express comfortability in prescribing Jesduvroq to their dialysis patients now that it is approved.  However, the bulk of physicians remain more cautious and likely to be highly selective. Interestingly, many also report they would be comfortable administering Jesduvroq three-times-per-week (corresponding to dialysis sessions), instead of the recommended daily dosing.
With the pending US launch of Jesduvroq and the potential for other HIF-PHI assets to re-file new drug application packages to the FDA given their approvals in other global regions, the anemia of CKD landscape is certain to change. Spherix will be tracking key launch performance metrics – including monthly tracking and quarterly deeper quantitative-qualitative analysis through its
Launch Dynamix: Jesduvroq series, kicking off in March 2023, in addition to pulsing the overall anemia treatment market and patient care trends through its other services.
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 a monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into patient types initiated, brand perceptions, promotional activity, and drivers and barriers to uptake.
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.
Meghan Weiss, Nephrology Insights Director
[email protected]
Scott Upham, Corporate Communications
[email protected]
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.
Jesduvroq (daprodustat) approved by US FDA for anemia of chronic kidney disease in adults on dialysis | GSK US
SOURCE Spherix Global Insights
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