Wayrilz (rilzabrutinib, Sanofi) Positioned to Define Third-Line Treatment in Warm Autoimmune Hemolytic Anemia (w-AIHA) as IMAAVY (niopcalimab, Jonhson & Johnson) Follows Closely with Positive Data Announcement at EHA 2026
Exton, PA, June 12, 2026 (GLOBE NEWSWIRE) -- Despite widespread recognition that long-term steroid exposure should be minimized in patients with warm autoimmune hemolytic anemia (w-AIHA), treatment patterns remain heavily reliant on corticosteroids and rituximab, highlighting significant unmet need for new therapeutic options. Findings from the newly released Market Dynamix™: AIHA (US), 2026 study from Spherix Global Insights reveal growing physician anticipation for late-stage pipeline agents, with Sanofi's rilzabrutinib generating the strongest interest among hematologists as they seek durable, steroid-sparing treatment options for patients who progress beyond current standards of care.
The study, which surveyed 71 U.S. hematologists managing patients with AIHA, found that corticosteroids remain the overwhelming first-line standard, while rituximab is firmly established in second line. Yet physicians report that only half of patients treated with corticosteroids are both responding well and tolerating therapy, reinforcing concerns about the limitations of existing treatment approaches.
While nearly all hematologists agree that avoiding long-term steroid exposure is an important treatment objective, current treatment paradigms have remained largely unchanged. The continued reliance on therapies that many physicians acknowledge are imperfect underscores the need for additional options, particularly for patients who relapse, become refractory, or require prolonged steroid use.The research highlights a treatment landscape that becomes increasingly fragmented beyond second line. While corticosteroids and rituximab occupy clearly defined positions early in the treatment journey, physicians report no consensus third-line approach. Instead, they utilize a broad mix of immunosuppressants, splenectomy, intravenous immunoglobulin (IVIG), erythropoiesis-stimulating agents (ESAs), and chemotherapeutic agents. This lack of standardization creates a meaningful opening for novel therapies capable of establishing themselves as preferred options in refractory disease.
Against this backdrop, hematologists are increasingly focused on the next generation of therapies. Among the late-stage pipeline agents evaluated, rilzabrutinib (currently marketed as Wayrilz for immune thrombocytopenia [ITP], Sanofi), nipocalimab (currently marketed as Imaavy for generalized myasthenia gravis [gMG], Johnson & Johnson) and ianalumab (Novartis) are contributing to growing physician optimism that the w-AIHA treatment landscape may soon evolve beyond longstanding reliance on steroids and rituximab.
Rilzabrutinib stands out in physician evaluations, with nearly six in ten hematologists identifying the BTK inhibitor as the pipeline therapy they are most eager to see become available. Physicians also view rilzabrutinib as particularly well positioned to displace some of the immunosuppressive therapies currently utilized in later lines of care.
At the same time, hematologists also demonstrate meaningful awareness and consideration of other late-stage assets. Interest in ianalumab continues to grow year over year, reflecting enthusiasm for novel B-cell-targeted approaches, while nipocalimab remains firmly on physicians' radar as potential FcRn-targeting entrant. Together, these therapies reinforce expectations that meaningful innovation is approaching a disease area that has seen limited advancement in recent years. Importantly, physicians envision many of these emerging therapies first establishing themselves in third-line and later treatment settings, where the absence of a clearly preferred standard of care creates opportunities for differentiation. However, hematologists also indicate a willingness to move effective therapies earlier in the treatment paradigm if they demonstrate durable efficacy, activity in refractory patients, and meaningful steroid-sparing benefits.
These preferences align closely with evolving physician priorities. Durable responses remain the most desired attribute for new therapies, while interest in treatments that reduce or eliminate steroid dependence has increased compared to prior years. As new agents approach the market, treatment decisions may increasingly be driven by long-term disease control and reduced treatment burden rather than historical prescribing patterns alone.
As the competitive landscape advances toward a new era, physicians are signaling readiness for multiple novel mechanisms that could reshape treatment decision-making in w-AIHA. While rilzabrutinib currently commands the strongest physician interest, both ianalumab and nipocalimab remain important components of the evolving competitive outlook as hematologists evaluate future options for patients requiring treatment beyond corticosteroids and rituximab.
Market Dynamix™: AIHA (US), 2026 was fielded among 71 U.S. hematologists between April 10 and April 29, 2025. The report provides comprehensive insight into treatment patterns, unmet needs, competitive dynamics, patient management, and perceptions of emerging therapies in autoimmune hemolytic anemia.
About Market Dynamix™
Market Dynamix™ is an independent, data-driven service focused on understanding the evolving dynamics of specialty markets poised for disruption. Leveraging quantitative and qualitative research, the service evaluates current treatment approaches, unmet needs, and likely impact of pipeline agents over a three-to-five-year horizon.
About Spherix Global Insights
Spherix Global Insights is a leading independent provider of market intelligence and advisory services for specialty pharmaceutical and biotech markets. By combining physician, patient, and payer perspectives into a single integrated view, Spherix helps brand teams, market access stakeholders, and investors understand how a specialty market actually behaves, not how any one stakeholder describes it. The firm operates eight dedicated therapeutic franchises – Central Nervous System, Dermatology, Gastroenterology, Hematology, Nephrology, Oncology, Ophthalmology, and Rheumatology – alongside a fully dedicated Market Access team. Each franchise is led by hyper-focused analysts and researchers who track these specialty areas full-time, drawing on independently curated communities of vetted practicing specialists, KOLs, patients recruited through treating physicians and advocacy partners, and medical and pharmacy directors at commercial and government payers. Spherix delivers quarterly trending, launch tracking, chart audits, KOL synthesis, patient experience research, and payer and market access intelligence that support confident, strategic decision-making across the pharma lifecycle. Trusted by 19 of the top 20 pharmaceutical and biotech organizations, Spherix has been a go-to resource for more than a decade for leading brands, market access stakeholders, industry media outlets, financial analysts, professional organizations, and patient advocacy groups seeking an unbiased, holistic view of specialty markets.
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Spherix Global Insights Contacts
Sarah Hendry, Hematology Franchise Head
sarah.hendry@spherixglobalinsights.com
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