Spherix Global Insights

November 13, 2019

Nephrologists Report Strong Willingness to Prescribe Off-Label Agents for Various Glomerular Diseases, According to Recent Market Intelligence from Spherix Global Insights

Conditions such as diabetic nephropathy, IgA nephropathy, focal segmental glomerulosclerosis (FSGS), and lupus nephritis are associated with high unmet need

 EXTON, Pa., November 13, 2019/ PRNewswire/ — Throughout 2019, Spherix Global Insights has been collaborating with US nephrologists to identify areas of high unmet need and to detect late-stage clinical candidates with the most promise. Glomerular diseases consistently top the list of conditions with the highest unmet need, along with acute kidney injury (AKI) – being rated much higher than conditions with an array of pharmaceutical treatments such as renal anemia, hyperkalemia, and secondary hyperparathyroidism. The American Society of Nephrology meeting was held in Washington, D.C. last week, and many companies with later stage assets showcased their data, including Retrophin (sparsentan for FSGS and IgA), Omeros (narsoplimab for IgA), Aurinia Pharmaceuticals (voclosporin for lupus nephritis), and Reata Pharmaceuticals (bardoxolone for Alport’s Syndrome, IgA, and FSGS), among others.

Two common themes across all glomerular diseases include the desire to minimize exposure to steroids and the willingness to use products off-label. In Spherix’s Market Dynamix™: IgA Nephropathy service, 107 US nephrologists were surveyed about their treatment patterns for patients with IgA nephropathy. Eighty-four percent reported a high unmet need for new pharmacologic agents, but only 20% had unaided awareness about specific pipeline products despite a healthy number of unique and novel mechanism agents in development. More than one-third of the respondents reported some off-label use of rituximab; a similar percentage reported experience with HP Acthar gel to treat IgA. The majority of nephrologists agree that the nephrology community does not have a good understanding of the cause(s) of IgA nephropathy, and there is a healthy divide among these specialists as to the difficulty in predicting which patients may have rapid progression. Clearly, this is a market where not only new products, but new basic research and education is desperately needed.

Spherix also conducted a project with over 200 nephrologists and rheumatologists, Market Dynamix™: Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN), which included a self-administered survey and a patient chart review of 1,032 patients with moderate-to-severe lupus. Both specialists reported that more than half of their SLE and LN patients had experienced a flare in the past year, and steroid minimization was a major goal of both specialties. Rheumatologists reported that the biggest change in the past year was increased use of GSK’s Benlysta, at least partially fueled by the introduction of a subcutaneous formulation. The percentage of SLE patients being treated with Benlysta is low, but the potential for growth seems favorable as rheumatologists report that among SLE patients not currently treated with Benlysta, more than one-third are good candidates for the drug; an expanded indication in LN would provide the greatest boost. The study also examined important attributes for pipeline agents, gauged familiarity with late-stage compounds, and queried on the most desired agents. For rheumatologists, Janssen’s Stelara and Eli Lilly’s Olumiant, both approved for other autoimmune conditions, topped the “most wanted” list. In LN, nephrologists are most desirous of an expanded indication for Benlysta and approval of Roche-Genentech’s Gazyva (obinutuzumab), while they seem to be less impressed with Aurinia Pharmaceutical’s voclosporin.

Finally, in an exciting era for the renal community, the FDA recently approved Janssen’s Invokana (canagliflozin) for diabetic kidney disease, which addresses a population with few treatment options. Acting quickly following the September approval, renal-giant Vifor Pharma signed a commercial deal with Janssen to support promotion to the nephrology audience. Market Dynamix™: Diabetic Kidney Disease (US), a Spherix study based on a survey conducted just weeks ago with more than 300 US nephrologists, cardiologists, endocrinologists, and primary care physicians examines how this new approval will affect SGLT2 treatment rates. The project also measures familiarity with and reaction to nine late-stage pipeline agents, with emphasis on Bayer’s finerenone, a novel, non-steroidal, mineralocorticoid antagonist. The report is scheduled for release in late November.

About Market Dynamix™
Market Dynamix™ is an independent service that utilizes a combination of qualitative and quantitative market research to explore the future dynamics of evolving healthcare treatment paradigms. The qualitative analysis is fueled by interviews with nephrologists in the trenches. The quantitative portion leverages our proprietary network of specialists coupled with robust patient chart analysis for sizing the market and to understand current perceptions, gaps in product awareness, and unmet needs.

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.

In addition to in-depth coverage of glomerular diseases, Spherix has also recently published independent reports on the following markets: metabolic acidosis, FSGS, hyperphosphatemia, renal anemia, autosomal dominant polycystic kidney disease, hyperkalemia, secondary hyperparathyroidism, chronic kidney disease, and incident/prevalent dialysis.

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

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