Spherix Global Insights

April 30, 2024

EU Nephrologists Foresee Travere/CSL Vifor’s FILSPARITM (sparsentan) Transforming IgA Nephropathy Treatment as the First Non-Immunosuppressive Therapy

Data from Spherix Global Insights’ second annual EU IgAN patient chart audit indicates that even with the EMA approval of FILSPARITM (sparsentan), opportunities for pipeline agents to make an impact remain.

EXTON, PA., April 30, 2024 – Over the past several years, glomerular diseases have garnered significant attention from the nephrology industry, largely driven by the persistent unmet needs present for patients grappling with these rare conditions. With a range of approved products and a thriving pipeline, IgA nephropathy (IgAN) has emerged as a focal point of innovation in the field. The latest milestone in this trajectory is the European Medicines Agency’s (EMA) conditional approval of Travere/CSL Vifor’s FILSPARITM (sparsentan) for the treatment of primary IgAN patients with a urine protein excretion ≥1.0g/day (or urine protein-to-creatinine ratio ≥0.75 g/g), announced on April 24, 2024.

Findings from Spherix Global Insights’ second annual Patient Chart DynamixTM: IgA Nephropathy (EU5) study reveal a dynamic landscape, as evidenced by the analysis of 514 IgAN patient records collected in collaboration with 272 nephrologists across the United Kingdom, Germany, Italy, Spain, and France. The data underscores ongoing evolution in the approach to IgAN treatment, marked by a rising adoption of SGLT2 inhibitors and growing utilization of Kinpeygo in Germany. Of note, EU5 physicians continue to seek to minimize the use of systemic corticosteroids and other immunosuppressive agents in this patient population, highlighting the opportunity for newer agents to further evolve the treatment paradigm.

Despite the increased utilization of SGLT2 inhibitors in earlier lines of therapy, often coupled with ACE inhibitors and ARBs, approximately half of patients persist with proteinuria levels surpassing 1.0g/day. This underscores the pressing need for novel therapies to enhance patient outcomes effectively. Moreover, there is a growing demand for products that demonstrate substantial preservation of kidney function, as physicians anticipate that a majority of IgAN patients will eventually require dialysis.

When surveyed early in 2024, EU5 nephrologists indicated the highest level of familiarity with sparsentan among the pipeline agents under development for IgAN. As the pioneering non-immunosuppressive therapy poised for approval, sparsentan also boasted the highest rates of patient candidacy among the audited patients, followed by atrasentan (Novartis/Chinook), ravulizumab (Alexion), and iptacopan (Novartis).

When considering patient candidacy for the various pipeline therapies, physicians often indicate that they will base their treatment decisions on comorbidities, proteinuria levels, rate of eGFR decline, and a multitude of other factors. Notably, some nephrologists are not perceiving a large difference between FILSPARITM (sparsentan), a dual endothelin angiotensin receptor antagonist (DEARA), and atrasentan, an oral endothelin-A receptor antagonist (ERA). This lack of perceived differentiation, despite the mechanism of action and expected efficacy of the agents, highlights the potential competitive dynamics that the market will face once additional products are launched, and further underscores the importance of physician education to help advance patient care.

Spherix’s recent Market DynamixTM: Rare Glomerular Diseases (EU5) study offers an additional comprehensive examination of the evolving landscape across various glomerular diseases to further benchmark the relative unmet needs and excitement around the pipelines. In this study, 206 EU5 nephrologists shared their perspectives on the evolving market dynamics in IgAN, focal segmental glomerulosclerosis (FSGS), C3 glomerulopathy (C3G), ANCA-associated vasculitis (AAV), Alport syndrome, IgA vasculitis (IgAV), membranous nephropathy, lupus nephritis, aHUS, and minimal change disease (MCD). The findings revealed numerous challenges faced by respondents in treating patients with rare kidney diseases, notably a deficiency in effective treatment options.

Spherix will continue to track the developing IgAN markets in the US, EU, Japan, and China. With the anticipated introduction of new therapies from Novartis/Chinook, Alexion, Vera Therapeutics, Otsuka, Ionis/Roche, Alnylam, and other companies, the landscape of IgAN treatment is poised for further evolution, prompting ongoing changes in the treatment paradigm.

Patient Chart 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.

Market Dynamix™ is an independent service providing analysis of markets anticipated to experience a paradigm shift within the next three to five years. Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.

About Spherix Global Insights

Spherix Global Insights is a leading provider of market research, business intelligence and advisory services to the global life sciences industry. The company’s unique service offerings are powered by deep therapeutic knowledge, the Spherix Network specialty physician panel, and commercially relevant analyses to enable strategic decision-making by our valued customers.

A trusted advisor and industry thought leader, Spherix Global Insights provides specialized market expertise in six (6) focused therapeutic areas including: dermatology, gastroenterology, nephrology, neurology, rheumatology, and ophthalmology.

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Spherix Global Insights Contact

Meghan Weiss, Nephrology Franchise Head

[email protected]

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