Spherix Global Insights

September 17, 2019

US Nephrologists Beginning to Trial AstraZeneca’s LOKELMA (zirconium sodium cyclosilicate) but Unclear on Differentiation from Vifor/Relypsa’s VELTASSA (patiromer FOS)

According to Spherix Global Insights, nephrologists surveyed in August report increased promotion and associated familiarity with Lokelma but express concerns about potential effects of sodium content.

EXTON, Pa., / September 17, 2019 / PRNewswire – After two Complete Response Letters resulting in lengthy approval delays, AstraZeneca was finally able to introduce Lokelma, its novel treatment for hyperkalemia, to the US market earlier this year.  Lokelma was acquired from ZS Pharma in 2015 for $2.7 billion.

In the latest quarterly wave of research with US nephrologists (n=105), which has been on-going since Q1 2016, participants were surveyed about their use of Lokelma, Veltassa, and other interventions for hyperkalemia in the outpatient, inpatient, and dialysis settings.  Compared to the prior quarter, familiarity with Lokelma increased significantly largely as a result of sales force efforts.  Trial rates also increased significantly from the prior quarter with just under half of those surveyed reporting some use of Lokelma, predominantly in the outpatient setting.

While overall nephrologists are pleased to have additional options, since the introduction of Veltassa the unmet need rating for new products to treat hyperkalemia predictably declined.  Prior to the launch of Veltassa, 65% indicated there was a high unmet need; today, that figure stands at just 26%.  In the non-dialysis setting, significantly higher need is placed on new treatment options for diabetic nephropathy, acute kidney injury, and certain glomerular conditions such as FSGS and IgA nephropathy.

Although 62% of the respondents agree with the statement “Lokelma and Veltassa will compete for the same patients in my practice,” share projections in the next six months suggest that Lokelma poses a greater threat to sodium polystyrene sulfonate (SPS, Kayexalate, Kionex) – across all settings.  Indeed, in Q3 2019, Veltassa actually achieved a new all-time high in both user base (95%) and number of patients treated, indicating little (if any) cannibalization at this point.

In some patient types, nephrologists do have a stronger preference for one of the novel agents; an example being patients with heart failure, in which Veltassa is preferred 4:1 over Lokelma, presumably tied to concerns about sodium exposure.  For patients on multiple medications or those hospitalized with acute hyperkalemia, Lokelma is preferred 3:1 over Veltassa.  Preference and share projections indicate that setting may prove to be the differentiator, with the majority of respondents selecting Veltassa as the potassium lowering agent of choice in the outpatient setting and more than 40% choosing Lokelma as the inpatient agent of choice.

More than one-third of those surveyed intend to increase their use of Veltassa in the next three months, while more than half anticipate increased use of Lokelma. Although market access barriers (prior authorization requirements, out of pocket costs, etc.) will impact both brands, close to one-third of the respondents report that potential issues with sodium content (e.g. edema) is a barrier to Lokelma, while a similar percentage indicate that the dose separation requirement is a barrier to Veltassa.

Spherix will continue to track the hyperkalemia market evolution in its monthly mini-pulse through the rest of 2019 and its quarterly series of RealTime Dynamix™: Hyperkalemia (US) which will continue through 2020.

About RealTime Dynamix™
RealTime Dynamix™: Hyperkalemia (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.

Spherix was recently recognized by Philadelphia Business Journal as a 2019 Soaring 76 recipient for the fastest growing companies in the Greater Philadelphia area and by The Philadelphia Inquirer as an Entrepreneurs’ Forum 2019 Philadelphia 100® Winner for the fastest growing privately-held companies in the Greater Philadelphia area.

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For more information contact:
Jake B. Guinto, PhD, Cardio-Renal Insights Director
Phone: (484) 879-4284
Email: info@spherixglobalinsights.com

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