EXTON, PA, March 14, 2024 (GLOBE NEWSWIRE) -- The past several years have brought a transformative shift to the IgA nephropathy (IgAN) treatment landscape, including the introduction of two new targeted therapies, TARPEYO (budesonide) and FILSPARI (sparsentan), with additional novel therapies on the horizon. A number of companies, including Novartis, Vera Therapeutics, Otsuka/Visterra, Alexion, Roche/Ionis, Alnylam, Apellis, HiBio/MorphoSys, and others have assets in development to treat IgAN, some in both the US and EU, promising further evolution and increased competitive dynamics in these markets.
For several years, Spherix Global Insights has been closely tracking the IgAN market and recently released its fourth annual US patient chart audit study. This data, which was fielded to 142 nephrologists in early 2024 and included the records of more than 450 IgAN patients, reveals a contrast between perception and reality in IgAN patient care. Most notably, physicians generally identify their patients to be in “excellent” or “good” overall health, while concurrently classifying many as having an eGFR decline of up to 3 mL/year, with some progressing even more rapidly (>3 mL/year), figures typically associated with renal failure.
Within the shifting treatment paradigm, SGLT2 inhibitor treatment rates in IgAN patients have continued to climb year-over-year, with the percentage of IgAN patients who are currently on a combination of ACEi/ARB and an SGLT2 inhibitor therapy having more than doubled over the past two years. As TARPEYO and FILSPARI are gaining a foothold in the market, nephrologists are primarily positioning the agents as third- and fourth-line therapies after ACEi/ARBs and SGLT2 inhibitors, with some controversy as to when to use each. Despite these changes in treatment, nearly half of the audited IgAN patients continued to have a UPCR of 1.0 g/g or greater at their most recent measure, highlighting the unmet need that remains in the space.
Earlier this year, Calliditas received full FDA approval for TARPEYO, and Travere is now on a parallel trajectory, having recently submitted a supplemental NDA for full approval of FILSPARI in IgAN just this month. With the conversion of the existing accelerated approval of both products to full approval, Calliditas and Travere will have an opportunity to capitalize on their first- and second-to-market positions with an expanded patient pool for their respective products.
In the realm of IgAN pipeline agents, atrasentan (Chinook Therapeutics, a Novartis company) and iptacopan (Novartis) have emerged as the most recognized and familiar among nephrologists, with both poised for FDA NDA submissions in 2024. Additionally, there was a significant uptick in nephrologists' awareness of Vera Therapeutics’ atacicept this year, and the company recently unveiled encouraging Phase IIb data from the agent’s ORIGIN trial for atacicept in January 2024. Furthermore, sibeprenlimab (Otsuka/Visterra) was granted Breakthrough Therapy designation by the FDA for IgAN treatment in February of this year, following promising results from its Phase II ENVISION trial.
Developments are also swiftly unfolding in the EU, with Spherix set to release its second annual study this week, featuring data from 514 patients gathered through collaboration with 272 nephrologists. Last year, EU nephrologists identified nearly half of their IgAN patients as potential candidates for novel therapies, showing a strong inclination to prescribe iptacopan and atacicept. However, with the recent positive recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) for the approval of sparsentan, this landscape is poised for change in 2024. As these pipeline agents, alongside others, achieve significant milestones in their respective trials, Spherix remains dedicated to assisting manufacturers in staying abreast of the latest shifts in treatment goals and paradigms.
Spherix is the leading authority on IgAN market dynamics and will continue to provide insight into how nephrologists are treating and approaching care for their IgAN patients. In addition to the US and EU, Spherix has also conducted IgAN patient chart audits in both the Japan and China markets, with the next installments planned for 2025.
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.
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.
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