The IgA Nephropathy Landscape Has Experienced Rapid Changes Over Past Two Years with Increased Use of SGLT2 Inhibitors and Tarpeyo (Calliditas); More Change on The Way with Filspari (Travere) Launch, According to Spherix Global Insights

Spherix Global Insights announces the release of its third annual US IgAN patient chart audit showing major shifts in IgAN patient treatments, with additional audits in the EU5, China, and Japan coming soon.

EXTON, Pa., March 15, 2023 /PRNewswire/ -- Focus on glomerular diseases has intensified over the past few years as products have advanced in development and nephrologists increasingly identify glomerular diseases as a leading area of interest. Tarpeyo (Calliditas) led the field as the first FDA approved product specifically for IgA nephropathy one year ago, while Travere recently achieved approval for Filspari (sparsentan) in mid-February 2023.

Spherix Global Insights has been tracking the rare glomerular disease market – and IgA nephropathy (IgAN) specifically – closely over the past five years, and recently released its third US patient chart audit study of more than 450 patients. This study highlights evolving trends in patient management, continued unmet needs for patients, and perceptions and opportunities for upcoming pipeline agents – such as cemdisiran (Alnylam), atacicept (Vera), sibeprenlimab (Otsuka/Visterra), and narsoplimab (Omeros).

The US patient chart audit, fielded among 152 nephrologists in early 2023, revealed that nephrologists believe two-thirds of their IgAN patients have moderate to severe disease, and that more than one-in-ten have moderate to high disease activity. Notably, nearly one-quarter of patients with a recent urine protein-to-creatinine ratio (UPCR) had values of 1.5g/g or higher. This is of particular importance given Calliditas' TARPEYO™ is indicated in IgAN patients "at risk of rapid disease progression" and with a UPCR at or above 1.5g/g.

FILSPARIᵀᴹ (sparsentan), a non-immunosuppressive therapy for the reduction of proteinuria in IgAN, is also indicated for patients with a UPCR of 1.5g/g or higher. FILSPARI's product label contains a Boxed Warning for hepatotoxicity and birth defects and has an associated Risk Evaluation and Mitigation Strategy (REMS) program. In the patient chart audit, nephrologists identified approximately one-half of their IgAN patients as potential candidates for Filspari. Conversely, in Spherix's Launch Dynamix™: FILSPARI service, US nephrologists were a bit more realistic, projecting that roughly one-quarter of their overall IgAN patient pool may be candidates for the product (similar to projections for TARPEYO candidacy upon launch).

One nephrologist interviewed as part of the Launch Dynamix study suggested why projections on the patient candidate pool might go beyond what the indication implies: 

"To wait until the horse is out of the barn and the barn's fire, makes no sense to me. Not only would I treat people with 1 g/g (proteinuria), I would treat well earlier… [than wait until proteinuria reaches 1.5g/g]."

Nephrologists report significant excitement about using these new IgAN therapies. However, the question remains as to whether new therapies will expand the patient pool or whether new entries will be in competition for the same patients. Another factor will be the growing use of SGLT2 inhibitors among patients with glomerular diseases – which has increased seven-fold over the past two years.

As the market matures with possible new therapies from Chinook, Ionis, Novartis, Omeros, Otsuka, and Vera, Spherix will provide insight into the changing treatment algorithm within the IgAN treatment space. The next update on IgAN launches will be released in early April 2023, along with additional IgAN patient chart audits in the EU5 (Germany, United Kingdom, Spain, Italy and France), China and Japan.

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 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 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.

To learn more about Spherix Global Insights, visit spherixglobalinsights.com or connect through LinkedIn and Twitter.

Spherix Global Insights Contacts

Blaine Cloud, Franchise Leader, Nephrology
[email protected]

Scott Upham, Corporate Communications
[email protected]

NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement by any company, brand, or product aforementioned.

SOURCE Spherix Global Insights