Exton, Pennsylvania, Oct. 13, 2023 (GLOBE NEWSWIRE) -- The FDA's recent approvals of Calliditas' Tarpeyo (budesonide) and Travere's Filspari (sparsentan) to treat primary IgA nephropathy (IgAN) have elicited a resounding applause from nephrologists. Prior to the introduction of these groundbreaking agents, the therapeutic landscape for IgAN patients was notably limited, primarily relying on systemic corticosteroids. Despite the welcomed additions to the armamentarium, data from Spherix’s 2023 Market Dynamix: IgA Nephropathy (US) service reveals that nephrologists still consider there to be a high unmet need for new therapies.
The landscape of challenges in treating patients with IgAN seems to be undergoing a transformation with the introduction of Tarpeyo and Filspari. As a result, access has understandably become a more prominent and pressing concern, overshadowing the actual availability of disease-targeted treatment options. Moreover, as prescribers continue to gain experience with Tarpeyo and Filspari, they report that they are finding the ideal placement for both drugs as third- or later-line therapies, often prescribing them in combination with RAASi therapy (ACE inhibitor/ARB) and SGLT2 inhibitors, and underscoring a need for agents at all stages of treatment.
In August, Calliditas announced that the FDA has not only accepted but also granted priority review status to the submission for the supplemental New Drug Application (sNDA) for Tarpeyo. This sNDA is founded on the full dataset from the Phase 3 NefIgArd clinical trial1. If granted full approval, Tarpeyo would become accessible for prescription to all IgAN patients, rather than being limited to those specifically identified as at risk for rapid progression. A noteworthy portion of the surveyed nephrologists voiced their anticipation that full approval would markedly enhance their utilization of Tarpeyo, potentially addressing some of the existing treatment needs.
The landscape of the IgAN pipeline is in a constant state of evolution, with one of the most recent developments coming from Novartis. The company has recently unveiled positive interim results from the Phase III APPLAUSE-IgAN study, demonstrating the superiority of iptacopan over placebo in reducing proteinuria. This groundbreaking achievement translates into a clinically meaningful and highly statistically significant proteinuria reduction on top of supportive care in IgAN patients.2
With its recent acquisition of Chinook, Novartis is solidifying its position as a key player in the IgAN market. This strategic move has fortified the company's IgAN pipeline with valuable additions like atrasentan and zigakibart (BION-1301). Notably, survey findings indicate that nephrologists hold both iptacopan and atrasentan in high regard, ranking them among the top products they eagerly await approval for in the realm of IgAN treatment.
Nevertheless, numerous other agents within the IgAN pipeline have captured the attention of nephrologists. These include atacicept (Vera), narsoplimab (Omeros), cemdisiran (Alnylam), sibeprenlimab (Otsuka/Visterra), BCX10013 (BioCryst), Ultomiris IV, vemircopan (Alexion), and felzartamab (HiBio/MorphoSys). Insights derived from Spherix's latest Patient Chart Dynamix™: IgA Nephropathy (US) study, a collaborative analysis of 439 IgAN patient records supplied by 156 US nephrologists, reveal that practitioners familiar with these pipeline assets anticipate that patient eligibility rates are poised to soar, reaching levels exceeding 60% for certain products. As IgAN treatment continues to evolve, nephrologists report an aim to achieve several key goals, such as delaying CKD progression and lowering proteinuria.
With the introduction of innovative products like Tarpeyo and Filspari into the market, Spherix takes an active role in monitoring their performance during the initial 18 months post-launch through its Launch Dynamix™ tracking series. This comprehensive service offers monthly evaluations of key performance metrics that are benchmarked to analogue launches, as well as quarterly in-depth quantitative and qualitative research, which provide insights into key variables that help assess a product’s success.
References:
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.
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 and demographic data, connecting trends at the patient level to the prescribing physicians.
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.
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