As the first treatment to gain FDA approval for metabolic dysfunction-associated steatohepatitis, Madrigal Pharmaceuticals’ Rezdiffra is poised to make a sizable impact on a condition with substantial unmet need.
Excitement grows as the FDA’s first approval for MASH treatment nears commercialization, according to Spherix Global Insights.
EXTON, PA, April 05, 2024 (GLOBE NEWSWIRE) -- As the first treatment to gain FDA approval for metabolic dysfunction-associated steatohepatitis (MASH), Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) is poised to make a sizable impact on a condition with substantial unmet need. As anticipation builds for the launch of Rezdiffra, Spherix Global Insights recently conducted a pulse survey among gastroenterologists (n=81) to assess prescriber feedback and projected uptake of the brand post-launch.
Results from the study reveal an overwhelming 82% of practitioners reported unaided awareness of Rezdiffra’s approval. Furthermore, 70% of gastroenterologists in the March 2024 pulse now report they are at least moderately familiar with Rezdiffra, a significant increase compared to April 2023.
When discussing the primary benefits of Rezdiffra, gastroenterologists highlight its distinction as the first indicated product for MASH, alongside its prospective efficacy in improving fibrosis. As expressed by one gastroenterologist, "[There were] no prior treatments for MASH except for lifestyle modifications and weight loss. Nice to have a daily oral pill to help reduce hepatosteatosis and possibly reverse liver damage.” Another underscores the advantages, noting, “statistically significant reduction in fibrosis stage for F2-3’s without NASH worsening. Good safety profile.”
Although surveyed gastroenterologists express enthusiasm for Rezdiffra, they also highlight several potential limitations for the brand, including concerns about possible side effects, cost, and the overall response rate. As one respondent remarks, "[There are] some GI side effects; efficacy results still leave a large number of F2-3 patients as non-responders.” Another offers, “The cost of almost $50,000 annually is problematic, so we will have to see what third-party payer barriers are thrown up to its use.”
Despite the potential drawbacks, rapid adoption of Rezdiffra is anticipated, with more than three-quarters expecting to trial the brand within six months of its launch. Furthermore, gastroenterologists indicate that over one-third of MASH patients under their care would be suitable candidates for Rezdiffra, further bolstering the likelihood of swift uptake and utilization.
Spherix will be closely monitoring the uptake of Rezdiffra for the first eighteen months of availability as part of the Launch Dynamix™ service, beginning in May. The service encompasses monthly key performance indicators, augmented by quarterly deep dives into promotional activity, barriers, and patient types gravitating to the launch brand.
Clients who pre-subscribed to Launch Dynamix™: Rezdiffra in MASH (US) received the full pre-launch analysis pulse last week.
Spherix will continue to track the MASLD/MASH treatment landscape, including key challenges and pipeline perceptions within the Market Dynamix™ service and will collect patient level data on the MASLD/MASH population via our inaugural Patient Chart Dynamix™ series.
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. 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 & 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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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.
Jim Hickey, Gastroenterology Franchise Head Spherix Global Insights 4848794284 Jim.Hickey@spherixglobalinsights.com
