Latest news with #Spherix
Yahoo
08-07-2025
- Health
- Yahoo
Market Barriers Continue to Challenge PNH Treatment Optimization Despite Emerging Options, According to Spherix Global Insights
New research highlights significant insurance-driven hurdles, increasing second-line uptake of Fabhalta (Novartis), and strong physician interest in pipeline therapies including zaltenibart (Omeros), pozelimab-cemdisiran (Regeneron/Alnylam), and ruxaprubart (NovelMed). EXTON, PA, July 08, 2025 (GLOBE NEWSWIRE) -- Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic blood disorder that can affect individuals of any age, race, or gender, though it is most commonly diagnosed in adults in their 30s and 40s. In the United States, an estimated 400 to 500 new cases are identified annually. The clinical presentation of PNH varies widely—some patients experience only mild symptoms, while others face life-threatening complications requiring interventions such as immunosuppressive therapy or blood transfusions. ¹ Hematologists are actively adapting their prescribing strategies in paroxysmal nocturnal hemoglobinuria (PNH), with future pipeline entrants poised to further reshape the treatment landscape. According to Spherix Global Insights' Q2 2025 update from RealTime Dynamix™: PNH (US), the availability and adoption of biosimilars are expected to significantly expand the overall treated PNH population—bringing more patients onto complement inhibitor therapy than ever before. The Spherix research projects that biosimilar eculizumab products—Bkemv (Amgen) and Epysqli (Teva/Samsung Bioepis)—will continue to gain traction, capturing share from both branded Soliris and Ultomiris (Alexion/AstraZeneca), as hematologists grow increasingly confident in the clinical utility and cost-effectiveness of biosimilar alternatives. Use of novel entrants in the second line is growing as well, with therapies such as Fabhalta (Novaratis) and Voydeya (AstraZeneca) capturing an increasing share of recent prescribing. These agents are selected for patients who progress or are sub-optimally controlled on C5 inhibitors. Despite these gains, access remains a major commercial hurdle. Many patients with PNH are believed to be suboptimally managed due to persistent insurance-related barriers. Nearly all prescribers report significant challenges navigating the prior authorization process, citing inconsistent payer requirements, delays in drug procurement, and a growing reliance on artificial intelligence by insurers to further restrict coverage. This evolving dynamic has become a major source of frustration for hematologists, often delaying timely access to appropriate therapies and complicating clinical decision-making. The competitive landscape in PNH continues to intensify, with future therapies gaining interest among both academic and community hematologists. The latest Spherix study incorporates target product profiles and prescriber expectations for emerging agents, including zaltenibart (Omeros), a MASP-3 inhibitor that has captured strong physician interest. Most hematologists anticipate zaltenibart will be adopted alongside existing first- and second-line therapies upon approval, driven by high efficacy expectations and its potential to address persistent unmet needs. Other late-stage candidates—such as pozelimab-cemdisiran (Regeneron/Alnylam) and ruxaprubart (NovelMed)—also register meaningful commercial and clinical potential among surveyed specialists. 'These results underscore that physicians aren't just passively watching the market evolve – they're preparing to act,' said Sarah Hendry, Hematology Franchise Head at Spherix. 'With rising expectations for access support and guideline alignment, manufacturers that combine clinical value with commercial enablement will be best positioned for success.' As was seen in Paris at the IPIG international conference when Spherix presented data from their Patient Chart Dynamix™, membership in critical professional societies is growing as hematologists seek the guidance in PNH treatments and care. The most recent release offers a comprehensive look at the U.S. PNH market, including prescribing patterns, brand dynamics, access challenges, and future projections. Delivered quarterly, RealTime Dynamix™ helps commercial teams anticipate shifts, benchmark against competitors, and support strategic planning ahead of key market events. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. Patient Chart Dynamix™ is an independent service that includes robust patient chart audits and integrated specialist surveys fielded biannually. This research provides an in-depth, real-world view of treatment practices by combining verified patient data with attitudinal insights from physicians. The series highlights clinical decision-making, treatment sequencing, and outcomes for targeted patient populations across key therapeutic areas. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: 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 of the companies or brands mentioned in this press release. CONTACT: Sarah Hendry, Hematology Franchise Head Spherix Global Insights 4848794284 in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Associated Press
08-04-2025
- Health
- Associated Press
Emerging IgAN Therapies Bring Hope – But Patients Still Face Emotional and Financial Barriers, According to Spherix Global Insights
EXTON, PA, April 08, 2025 (GLOBE NEWSWIRE) -- Spherix Global Insights has released the first edition of its new Patient Dynamix™: IgA Nephropathy (US) series, delivering a comprehensive look at the IgAN patient journey amid a rapidly evolving therapeutic landscape. As targeted treatments such as Tarpeyo (Calliditas), Filspari (Travere), Fabhalta (Novartis), and most recently Vanrafia (Novartis) enter the market, this research captures how patients are navigating diagnosis, treatment decisions, and the daily realities of living with this chronic kidney condition. Fielded in early 2025 and developed in collaboration with the American Kidney Fund (AKF), the study reflects the voices of 127 patients diagnosed with IgAN. While many report satisfaction with newer branded therapies, substantial gaps persist in patient education, confidence, and affordability. The emotional burden of an IgAN diagnosis remains significant, with most respondents describing initial feelings of fear, confusion, or anxiety. A clear need emerged for better disease education – particularly around treatment expectations, progression, and financial resources. More than one-third of patients rely on support groups or charitable foundations for financial assistance, underscoring the role pharmaceutical companies can play in reducing barriers through accessible, patient-friendly resources. The research places special emphasis on patients currently treated with Tarpeyo, Filspari, and Fabhalta, all of which are associated with symptom relief and improved quality of life. However, challenges persist. Although many patients begin treatment feeling informed, issues related to cost, insurance coverage, and long-term affordability often complicate therapy initiation and adherence. These findings highlight opportunities for manufacturers to enhance onboarding and support through both provider-facing tools and direct-to-patient engagement strategies. The study also integrates insights from Spherix's latest Patient Chart Dynamix™: IgAN (US) study to provide complementary perspectives from nephrologists, offering a comprehensive view of how patient and physician perceptions align, and differ, when it comes to disease severity, treatment satisfaction, and care coordination. For commercial, medical, and access teams preparing to launch or expand within the IgAN space, Patient Dynamix™: IgAN (US) offers a critical resource for shaping brand strategy, refining support services, and ultimately improving patient outcomes. By leveraging these patient-level insights, pharmaceutical organizations can more effectively tailor messaging, reduce drop-off rates, and enhance their position as true partners in IgAN care. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. About the American Kidney Fund The American Kidney Fund (AKF) fights kidney disease on all fronts as the nonprofit with the greatest direct impact on people with kidney disease. AKF works on behalf of 1 in 7 Americans living with kidney disease, and the millions more at risk, with an unmatched scope of programs that support people wherever they are in their fight against kidney disease—from prevention through transplant. AKF fights for kidney health for all through programs that address early detection, disease management, financial assistance, clinical research, innovation and advocacy. AKF is one of the nation's top-rated nonprofits, investing 97 cents of every donated dollar in programs, and it has received 24 consecutive 4-Star ratings from Charity Navigator as well as the Platinum Seal of Transparency from Candid, formerly known as GuideStar. AKF Contacts 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 of the companies or brands mentioned in this press release.
Associated Press
31-01-2025
- Health
- Associated Press
FDA Approval of Eli Lilly's Omvoh for Crohn's Disease Adds a New Option, but Uptake May be Hampered by US Gastroenterologists' Brand Preferences Among the IL-23 Class, According to Spherix Global Insights
EXTON, PA, Jan. 31, 2025 (GLOBE NEWSWIRE) -- The FDA's approval of Eli Lilly's Omvoh for Crohn's disease marks a significant milestone as the therapy becomes the second IL-23 inhibitor available for patients with this challenging condition. Omvoh, already approved for ulcerative colitis, now sets its sights on carving out a niche in the Crohn's disease market. Yet, stiff competition from AbbVie's Skyrizi and an expected approval for Johnson & Johnson's Tremfya raises questions about Omvoh's ability to stand out in Crohn's. Spherix Global Insights recently completed the Q4 2024 wave of its RealTime Dynamix™: Crohn's Disease (US) service, engaging with 101 U.S.-based gastroenterologists to evaluate the evolving Crohn's treatment landscape. Findings from this research highlight that while Omvoh enjoys greater familiarity among physicians compared to Tremfya, it faces hurdles in key pre-launch metrics. Nearly half of gastroenterologists view Tremfya as a significant advancement over existing options, compared to just one-third who believe the same for Omvoh. Moreover, over half indicate Tremfya as their preferred IL-23 inhibitor in development for Crohn's disease, while only 20% selected Omvoh. Despite these challenges, Omvoh sits within a class that is gaining momentum, with almost half of respondents citing IL-23s as the best overall mechanism of action for Crohn's treatment. Although TNF inhibitors including adalimumab and infliximab remain the mainstay for first-line biologic treatment in Crohn's, use of Skyrizi has grown steadily since it was approved, carving out share from the TNFs and Johnson & Johnson's Stelara. One gastroenterologist from the Spherix study who chose Omvoh as the preferred treatment in development note that the '[The] drug seems to have the right MOA to reduce inflammation and promote remission.' For Omvoh to grow alongside its fellow IL-23s, the product will need to carve out its own unique value proposition. Omvoh's initial indication in ulcerative colitis represented Lilly's first foray into the IBD space, and the brand has grown in share slowly but steadily since launch while facing competition from manufacturers with deep roots in gastroenterology. In ulcerative colitis, Omvoh focused on addressing bowel urgency – a critical patient concern. Gastroenterologists recognize addressing urgency is equally important in Crohn's disease, with more than two-thirds agreeing that it is an important treatment goal. A gastroenterologist in the Spherix study who indicated preference for Omvoh among treatments in development noted that it can provide 'Lasting remission and improved bowel urgency.' Spherix will closely monitor Omvoh's impact on the Crohn's disease market through its RealTime Dynamix™ service. In addition, Spherix will track Omvoh's performance during the first 18 months post-launch via the Launch Dynamix™ service, slated to begin in February 2025. With the IL-23 class continuing to gain traction, the coming months will reveal whether Omvoh can establish a unique foothold amid fierce competition. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. 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 Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit LinkedIn. 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 endorse.
