EXTON, Pa., June 18, 2020 /PRNewswire/ -- Millions of patients across the United States suffer from Type 2 diabetes, and one-quarter or more of those patients also have kidney disease, making diabetic kidney disease (DKD) one of the largest causes for morbidity and mortality in the country. Janssen's INVOKANA was approved in late 2019 as the first sodium-glucose cotransporter 2 (SGLT2) inhibitor to reduce the risk of end-stage kidney disease (ESKD), worsening of kidney function, cardiovascular death, and hospitalization for heart failure in adults with type 2 diabetes and DKD (nephropathy) with a certain amount of protein in the urine. Yet, nephrologists are reportedly still not entirely comfortable with this class.
In the latest quarterly report included in Spherix's RealTime Dynamix™: Diabetic Kidney Disease (US) service, more than one-third of nephrologists indicate trepidation about prescribing SGLT2 inhibitors for their DKD patients. Most claim they need more education and information about the class to be comfortable initiating therapy themselves, citing that managing diabetes falls more to the primary care physicians and/or endocrinologists. Indeed, among their patients currently being treated with SGLT2 inhibitors, only about 20% of respondents actually initiated the treatment themselves. The COVID-19 crisis has certainly not helped in this regard, as 95% of the surveyed nephrologists have had no interaction, neither face to face nor virtual, with an INVOKANA sales representative in the past month. Furthermore, about one in four indicate that they are not comfortable prescribing an SGLT2 inhibitor via telemedicine, which has become a practice norm in the current environment.
While nephrologists may be slow to fully embrace INVOKANA as a treatment for their DKD patients, they remain optimistic about the potential for this class to improve outcomes. However, Janssen's drug may soon have to share the renal limelight with AstraZeneca's FARXIGA. As of March 30th, 2020, AstraZeneca halted its Phase III trial ("DAPA-CKD") of FARXIGA as a treatment for chronic kidney disease (CKD) due to "overwhelming efficacy," and FARXIGA is likely to get approval not just for DKD, but also for renal patients without underlying Type 2 diabetes, in the near term. Indeed, nearly two-thirds of nephrologists expect their overall use of SGLT2 inhibitors to increase as a result of the FARXIGA approval, and over one-half expect to use the SGLT2 inhibitors more broadly in non-diabetic patients with CKD.
The introduction of more SGLT2 inhibitors to treat DKD may propel the class more firmly into nephrologist's armamentarium and decrease their apprehension in prescribing. However, it will also introduce competition across the class, which has already played out across the larger diabetes market. In an effort to control costs and extrapolate larger and larger rebates, managed care payers seek to drive use to one SGLT2 inhibitor over the others and will use out-of-pocket costs and cost-sharing tiers to accomplish their mission. Indeed, nearly half of nephrologists already identify out-of-pocket costs as a major barrier to prescribing INVOKANA – an aspect likely to worsen as the class expands within the indication.
The Spherix study also explored the pipeline for products being investigated for the treatment of DKD and noted that Bayer's finerenone and Novo Nordisk's OZEMPIC (semaglutide) were the leading preferred agents. Upon review of a profile for Novartis' nidufexor (LMB763), a farnesoid X receptor agonist, nephrologists acknowledged the uniqueness of drug, but were less impressed with the clinical trial design; over 90% however, indicated that, if FDA approved for DKD, the product would find a place in the DKD treatment paradigm.
The quarterly report series included in the RealTime Dynamix™: Diabetic Kidney Disease (US) service will continue to track the DKD launch/pre-launch of the SGLT2 inhibitors. In addition, the research covers promotion levels, messaging, trial rates, experience, and shifting treatment patterns in DKD, along with perceptions about pipeline assets and where they are likely to fit in the DKD treatment algorithm.
About RealTime Dynamix™
RealTime Dynamix™: Diabetic Kidney Disease (US) is an independent service providing strategic guidance through rapid and comprehensive quarterly reports, which include market trending, launch tracking, and a fresh infusion of unique content with each wave.
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.
SOURCE Spherix Global Insights