Unmet Need in Lupus Nephritis Finally Addressed with New FDA Approvals for GlaxoSmithKline's BENLYSTA (belimumab) and Aurinia Pharmaceuticals' LUPKYNIS (voclosporin)

EXTON, Pa., Jan. 25, 2021 /PRNewswire/ -- According to a survey of more than 200 US rheumatologists and nephrologists in mid-2020, the unmet need for new treatments for lupus nephritis (LN) is exceptionally high. At the time, unaided awareness for agents in development was primarily limited to Benlysta (particularly among rheumatologists) and Lupkynis (particularly among nephrologists). Overall, respondents were less familiar with agents such as Roche/Genentech's obinutuzumab (Gazyva), AstraZeneca's anifrolumab, Novartis' iscalimab, and BMS's oral TYK-2 inhibitor, deucravacitinib.  

With the Benlysta LN approval coming at year end (December 17, 2020) and Lupkynis just last week (January 22, 2021), nephrologists and rheumatologists have two new agents to add to their armamentarium. Although many rheumatologists already had off-label experience with Benlysta in LN, more than one-in-five report that the new indication will lift their current Benlysta use by more than one-third. However, both nephrologists and rheumatologists report that the majority of their LN patients are not clinical candidates for Benlysta, which could limit potential.

Regarding Lupkynis, both specialties see a sizeable market opportunity for this new agent. Notably, several respondents describe it as a potential best-in-class calcineurin inhibitor, a mechanism they are quite familiar with – which may help accelerate adoption. However, speed of prescribing is always a question; in mid-2020, only about 10-15% of the respondents expressed an urgency to prescribe the product "right away."

"The nephrology community is very comfortable with calcineurin inhibitors. I don't think it will be a tidal wave, but I do think that over time you will see voclosporin taking a higher percentage of the share of all stable use of calcineurin inhibitors." – Key opinion leader in nephrology

Beginning in February, Spherix will begin tracking the uptake and adoption of both Benlysta and Lupkynis in Launch Dynamix™, a new 18-month series consisting of monthly key performance indicators and quarterly quantitative deep dive reports. Quantitative data will be coupled with qualitative interviews to understand perceptions of each agent, their evolving places in the treatment paradigm, and projections for future use.

The series will be complemented by Spherix's Market Dynamix™ service, focusing on how the market is likely to evolve with new pipeline products in the coming years, and their RealWorld Dynamix™ service, including access to large-scale patient chart data from over 1,000 patients evaluating actual treatment algorithms.

Spherix will continue to track the developing pipeline in both systemic lupus erythematosus (SLE) and LN, as the plethora of products with novel mechanisms of action loom on the horizon. Survey respondents shared thoughts on what would be most desirable in new LN treatments:

• "We need something that allows for targeted management of nephritis with as quick a drop in the proteinuria and resulting secondary HTN control and edema as well"
• "We need more efficacious medicine with higher remission rate compared to mycophenolate"
• "Target specific therapy with better safety profile, no malignancy or fertility issues"
• "Something that induces renal remission, normalizes creatinine, and abolishes proteinuria that is safe and gets patients off of steroids"
• "An agent that addresses underlying pathophysiologic mechanism of SLE in general and can reverse or slow progression of renal damage"
• "A drug with higher than 55% remission rate and fewer side effects than current regimens"
• "We need agents that have less side effects. Unfortunately, we deal with a patient population that tends to be younger and need better options, so the treatment effects are worse than the actual disease process"
• "A drug that is given monthly or quarterly via IV infusion to ensure compliance"

The Lupus Foundation of America estimates that 1.5 million Americans, and at least five million people worldwide, have a form of lupus.^[1] As many as half of the patients with systemic lupus will develop nephritis.^[2] With new tools to fight this devastating disease, specialists may finally be able to bring hope to patients.

About Our Services

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.

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

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. 

Learn more about our services here.

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 dermatology, gastroenterology, nephrology, neurology, and rheumatology markets.

All company, brand or product names in this document are trademarks of their respective holders.

For more information contact:
Kristen Henn, Business Development Manager
Email: info@spherixglobalinsights.com
www.spherixglobalinsights.com

¹https://www.lupus.org/resources/lupus-facts-and-statistics 
²https://www.mayoclinic.org/diseases-conditions/lupus-nephritis/symptoms-causes/syc-20354335

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