Spherix Global Insights

June 30, 2022

High Unmet Needs Remain in Nephrology Despite Newly Approved Treatment Options According to Latest Research from Spherix Global Insights

Launch data tracking the market receptivity for Korsuva (Vifor/Cara Therapeutics), Kerendia (Bayer), Lupkynis (Aurinia Pharmaceuticals), and Tarpeyo (Calliditas) unveils gaps in patient care

EXTON, Pa., June 29, 2022 / PRNewswire / – A survey of 124 US nephrologists, conducted just last week, identifies acute kidney injury (AKI), diabetic kidney disease (DKD), and polycystic kidney disease (PKD) as areas physicians would most like to see new products approved to treat patients under their care.  New agents for glomerular diseases, including focal segmental glomerulonephritis (FSGS) and IgA nephropathy (IgAN) are also in high demand.

Over the past eighteen months, several renal drugs which were anticipated to be blockbusters and bring innovation to the category were dismissed by the FDA with Complete Response Letters (CRLs). These include novel HIF-PH inhibitors for anemia from Akebia (vadadustat) and FibroGen/AstraZeneca (roxadustat), a novel mechanism product for hyperphosphatemia from Ardelyx (tenapanor), and a product for a rare kidney disease, Alport Syndrome, from Reata Pharmaceuticals (bardoxolone methyl).

In prior Spherix research, following the receipt of these CRLs, many nephrologists expressed disappointment about the non-approval of the HIF-PH inhibitors, which are approved in countries outside the US, and tenapanor. While roxadustat and vadadustat look unlikely to be approved in the US anytime soon, tenapanor may have a potential lifeline with an upcoming Advisory Committee meeting.

Spherix’s Launch Dynamix series, which tracks metrics for newly approved products on a monthly basis, show a progressive expansion of the user base (the percent of physicians who have prescribed to any patients) for Lupkynis (for lupus nephritis) and Kerendia (for DKD) early post-approval; however, by month six, both drugs failed to reach a 50% user base among nephrologists. Tarpeyo, which was approved to treat IgAN at the end of 2021, initially struggled with trial among nephrologists, but its user base increased more than five-fold between months one and three.

Korsuva, for CKD-associated pruritus in hemodialysis patients, is the newest approved renal product that Spherix is tracking.  Korsuva was originally approved in August of 2021; however, the product didn’t officially launch until this past spring.  Early trends from June show that although there is relatively high awareness and a perception that Korsuva is a substantial advance over other treatment options, uptake has been tepid. Furthermore, only a limited number of nephrologists have an urgency to begin using the drug and more than one-quarter do not anticipate trial for at least six months. Given that nephrology is a promotion-sensitive specialty, Vifor may be able to accelerate adoption with increased reach from sales representatives, as fewer than half have been detailed on the drug. Adoption will also be highly dependent on any protocols for use put into place by dialysis organizations such as Fresenius Medical Care (FMC) and DaVita.

The next round of monthly results for products Spherix is tracking through its Launch Dynamix  service will be available to subscribed clients on July 15th.

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 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.

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