Spherix Global Insights

April 25, 2022

Spherix Uncovers Key Differences in the Management of Chronic Kidney Disease Patients in Europe Versus the U.S.

New analysis of European CKD non-dialysis patient chart data reveals notable differences in nephrologists’ use of renal therapies, including SGLT2 inhibitors

EXTON, Pa., / April 25, 2022 / PRNewswire – The approval of several renal pipeline products in the European market has granted nephrologists new options through which they can manage their patients with chronic kidney disease (CKD) – a population plagued with comorbidities and risks associated with disease progression. With the European Medicines Agency (EMA) trumping the U.S. Food and Drug Administration (FDA) in its approval and use of novel agents (e.g., EVREZNO [roxadustat]), Spherix experts have found notable differences in nephrologists’ treatment patterns between the two geographies.

Spherix recently published its inaugural patient chart audit included in their RealWorld Dynamix: CKD Non-Dialysis (EU) service, which highlighted the records of 1,282 CKD non-dialysis patients most recently seen by their nephrologist in France, Germany, Italy, Spain, and the UK. Findings from the EU audit varied from a parallel US chart audit (n=1,004 patient charts in 2021, its fifth annual series) when treatments used for diabetic kidney disease (DKD) and CKD, hyperkalemia, and anemia were analyzed.

One of the most notable dissimilarities was in the use of SGLT2 inhibitors. Indeed, nearly one-half of EU non-dialysis patients with DKD were currently being treated with an SGLT2 inhibitor compared to the one-third of DKD patients across the pond in the US. While AstraZeneca’s Forxiga/Farxiga (dapagliflozin) leads the market in terms of brand share in both regions, Janssen/Vifor’s Invokana (canagliflozin) and Eli Lilly/Boehringer Ingelheim’s Jardiance (empagliflozin) maintain greater share in the US than they do in the European countries.

Just recently, the EMPA-KIDNEY trial – a Phase III trial to evaluate the efficacy of Jardiance (empagliflozin) in non-diabetic CKD patients (for which Forxiga/Farxiga is already approved) was stopped early due to overwhelming efficacy. A second SGLT2 inhibitor approved for a non-diabetic CKD indication may continue to propel acceptance and use of this class in the CKD patient population to new heights.

Regardless of brand, the bulk of patients treated with an SGLT2 inhibitor in either geography are often initiated on therapy in CKD Stage 3 (with an eGFR between 30 and 50) in an effort to slow progression. Overall uptake of SGLT2 inhibitors in non-diabetic patients has been slow but is poised for growth in the near future.

Another area of fierce competition is in the hyperkalemia treatment market, where AstraZeneca’s Lokelma (sodium – zirconium cyclosilicate) and Vifor’s Veltassa (patiromer) battle head-to-head for share in both geographies. Interestingly, Veltassa and Lokelma together account for nearly four-in-ten CKD non-dialysis patients treated with a potassium-lowering agent in Europe, with Lokelma showing a slight lead over its competitor. In the U.S., the branded potassium binders account for a larger percentage of the market overall, with Lokelma again maintaining a slight edge over Veltassa.

One area of great controversy in the U.S. is the HIF-PH inhibitor class of drugs for the treatment of anemia of CKD, as the FDA recently rejected the second pipeline HIF-PH inhibitor product on the basis of safety concerns. Alternatively, in the EU, the EMA approved Astella’s HIF-PH inhibitor, EVRENZO, and uptake has been happening very gradually across the region. Despite the FDA rejections, U.S. nephrologists express high interest in the class and willingness to prescribe these pipeline assets.

Spherix will continue tracking these markets in both the U.S. and EU this year, with additional emphasis on dialysis patient chart audits in the U.S.

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 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 dermatology, gastroenterology, nephrology, neurology, and rheumatology markets.

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