As SGLT2 Inhibitors Create Increased Market Complexities for Chronic Kidney Disease Non-Dialysis Patients, How Quickly Will Patient Care Evolve – If at All?

According to new research published by Spherix Global Insights, the CKD non-dialysis market is poised for seismic shifts as SGLT2 inhibitors, including Invokana (Vifor (Relypsa)/Janssen), Farxiga (AstraZeneca), Jardiance (Eli Lilly/Boehringer Ingelheim), and Steglatro (Merck) embrace an expanded role in diabetic nephropathy and CKD patient care in 2021

EXTON, Pa., / March 4, 2021 / PRNewswire – Chronic kidney disease (CKD) patients experience a wide range of comorbidities and risks associated with their disease, such as diabetic complications, hyperkalemia, and metabolic acidosis. At the American Society of Nephrology (ASN) fall 2020 conference, Kidney Week Reimagined, news about SGLT2 inhibitors for CKD patients with and without diabetes created a stir and caused optimism about potential paradigm shifts for CKD patients.

The fierce competition between AstraZeneca and Vifor/Relypsa in the hyperkalemia market will likely spill into the SGLT2 inhibitor market in 2021, with potential additional complexities surrounding other in-class SGLT2 inhibitors (Eli Lilly/Boehringer Ingelheim’s Jardiance and Pfizer/Merck’s Steglatro), as well as the much-anticipated diabetic kidney disease (DKD) pipeline agent from Bayer, finerenone.

According to Spherix’s latest DKD research included in their RealTime Dynamix™: Chronic Kidney Disease (US) service, which captured insights from more than 100 US nephrologists, DKD represents one of the top unmet needs for new treatment options. Specifically, the lack of drugs to slow the progression of renal decline, along with poor patient compliance and multiple patient comorbidities, are highlighted as some of the greatest challenges in managing DKD patients – contributing to poor outcomes.

Results from the most recent chart audit included in Spherix’s RealWorld Dynamix™: Chronic Kidney Disease (US) service (an analysis of more than 1,000 CKD non-dialysis patients) found that more than 40% of CKD non-dialysis patients have type 2 diabetes, which represents a significant patient population and burden on nephrologists. Oftentimes, these patients progress rapidly and there is little nephrologists can do to stall their disease.

The SGLT2 inhibitors introduce a new layer of complexity (and hope) for DKD patients. There has indeed been growth (albeit slow) in nephrologists’ use of Invokana (Vifor (Relypsa)/Janssen), as it is the only SGLT2 inhibitor specifically approved for use in DKD patients. However, one-third of nephrologists remain trepidatious about prescribing SGLT2 inhibitors, indicating they prefer to not manage their patients’ diabetes – leaving that to PCPs and endocrinologists. This has been echoed by US cardiologists in other Spherix research.¹

New data on Farxiga (AstraZeneca) in CKD patients without diabetes appears promising as it awaits FDA approval.² While Spherix’s patient chart data reveals that only 8% of CKD non-dialysis patients overall are using SGLT2 inhibitors, brand share distribution for Farxiga over the past year has nearly doubled, stealing share directly from Invokana. Continuing to track brand use across DKD and non-diabetic CKD patients in coming months will be crucial to understanding how well brands are differentiating themselves, and how much physicians perceive the brands as interchangeable.

Despite these shifts and the general excitement for SGLT2 inhibitors (and for Farxiga in particular) across the nephrology community, nearly one-half of nephrologists express hesitation in prescribing these agents to non-diabetic CKD patients as of Q1 2021. Overcoming the reluctance to prescribe will be vital for the SGLT2 inhibitor class to be able to penetrate this new market base of DKD and CKD non-dialysis patients. Meanwhile, other pipeline products, most notably Bayer’s finerenone and Novo Nordisk’s GLP-1 analog Ozempic (semaglutide), have piqued nephrologists’ interest as well. In fact, more than one-third of nephrologists indicate they would prescribe finerenone within the first three months after its approval.

Markets are likely to collide in 2021, as AstraZeneca expands its renal reach into CKD and DKD with Farxiga. Their hyperkalemia/DKD portfolio of Lokelma and Farxiga will go in direct competition with Vifor/Relypsa’s portfolio of Veltassa and Invokana. Spherix Global Insights will be closely tracking quarterly changes in these markets as the year continues.

 About RealTime Dynamix™
RealTime Dynamix™: Chronic Kidney Disease (US) is an independent service providing strategic guidance through quarterly 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. Insights are based on data collected from an online survey of 100+ nephrologists recruited from the Spherix Network, a proprietary group of specialty physicians in clinical practice meeting quality screening criteria.

About RealWorld Dynamix™
RealWorld Dynamix™: Chronic Kidney Disease (US) 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. Insights are based on patient level data gathered through collaboration with specialty physicians who provide details on clinical and non-clinical patient demographics, along with their rationale for treatment choices.

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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:
¹Market Dynamix™: Diabetic Kidney Disease (US), 2020
²https://www.nejm.org/doi/full/10.1056/NEJMoa2024816