Press Release: Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
Riliprubart earns orphan drug designation in the US for antibody-mediated rejection in solid organ transplantation
Paris, June 25, 2025. The US Food and Drug Administration (FDA) has granted orphan drug designation to riliprubart for the investigational treatment of antibody-mediated rejection (AMR) in solid organ transplantation. This designation reflects Sanofi's commitment to addressing a critical unmet need in transplant medicine, where AMR remains a significant challenge with no FDA-approved treatments available. The FDA grants orphan drug designation to investigational therapies addressing rare medical diseases or conditions that affect fewer than 200,000 people in the US.
Alyssa Johnsen
Global Therapeutic Area Development Head, Immunology and Inflammation, Sanofi
'Orphan drug designation for riliprubart marks an important milestone in our mission to address critical challenges in transplant medicine leveraging our expertise in immunology. Antibody mediated rejection represents a serious threat to transplanted organs and patient survival. Through riliprubart's innovative mechanism of action, we hope to bring forward a treatment option that could significantly improve outcomes for kidney transplant recipients.'
Riliprubart is currently being explored in multiple clinical studies across different indications in transplant and neurology. A phase 2 clinical study is currently ongoing, exploring its potential in kidney transplant recipients ( NCT05156710 ). The study includes two patient cohorts: those at risk of developing rejection and those with active forms of antibody-mediated rejection. In addition, Sanofi is conducting two phase 3 studies exploring riliprubart in chronic inflammatory demyelinating polyneuropathy (CIPD), a rare neurological disorder, specifically in patients refractory to standard of care (MOBILIZE, clinical study identifier: NCT06290128 ), and in IVIg-treated patients (VITALIZE, clinical study identifier: NCT06290141 ). The broad clinical development program for riliprubart emphasizes Sanofi's commitment to exploring riliprubart's potential across multiple immune-mediated conditions with high unmet medical needs.
About Riliprubart
SAR445088 (riliprubart) is a potential first-in-class, IgG4 humanized monoclonal antibody that selectively inhibits activated C1s in the classical complement pathway of the innate immune system. Riliprubart is currently under clinical investigation, and its safety and efficacy have not been evaluated by any regulatory authority. For more information on riliprubart clinical studies, please visit www.clinicaltrials.gov.
About AMR
Antibody-mediated rejection is a serious complication that may arise after solid organ transplantation, occurring when the recipient's immune system produces antibodies that attack the transplanted organ. Sensitized recipients, who have pre-existing antibodies that target foreign antigens including those found on transplanted organs, face a high risk of developing antibody-mediated rejection. Subsequent immune response can lead to inflammation, organ damage, and organ failure if left untreated.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people's lives and delivering compelling growth. We apply our deep understanding of the immune system to invent medicines and vaccines that treat and protect millions of people around the world, with an innovative pipeline that could benefit millions more. Our team is guided by one purpose: we chase the miracles of science to improve people's lives; this inspires us to drive progress and deliver positive impact for our people and the communities we serve, by addressing the most urgent healthcare, environmental, and societal challenges of our time.
Sanofi is listed on EURONEXT: SAN and NASDAQ: SNY
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Sanofi forward-looking statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions, and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words 'expects', 'anticipates', 'believes', 'intends', 'estimates', 'plans' and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the fact that product candidates if approved may not be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi's ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic and market conditions, cost containment initiatives and subsequent changes thereto, and the impact that global crises may have on us, our customers, suppliers, vendors, and other business partners, and the financial condition of any one of them, as well as on our employees and on the global economy as a whole. The risks and uncertainties also include the uncertainties discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under 'Risk Factors' and 'Cautionary Statement Regarding Forward-Looking Statements' in Sanofi's annual report on Form 20-F for the year ended December 31, 2024. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
All trademarks mentioned in this press release are the property of the Sanofi group.
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During the decades reviewed: Deaths from arrhythmias had the largest relative increase, with the age-adjusted death rate rising by 450%. However, arrhythmias still accounted for only about 4% of all heart disease deaths in 2022. Arrhythmias occur when electrical impulses to the heart may be too fast, too slow or erratic, causing an irregular heartbeat. Atrial fibrillation is one of the most common types of arrhythmias. The age-adjusted death rate from heart failure — a chronic condition where the heart is unable to pump enough blood to meet the body's needs for blood and oxygen — increased 146%. The rate of deaths from hypertensive heart disease — heart problems that occur because of high blood pressure that is present over a long time — increased by 106%. In addition to analyzing the types of heart disease deaths, the researchers also identified several underlying factors that may account for the shift in deaths from ischemic heart disease to other heart conditions. 'Over the past 50 years, our understanding of heart disease, what causes it and how we treat it has evolved considerably. That's especially true in how we address acute cardiac events that may appear to come on suddenly,' King said. 'From the establishment and increased use of bystander CPR and automated external defibrillators to treat cardiac arrest outside the hospital setting, to the creation of systems of care that promote early recognition of and quick procedural and medical intervention to treat heart attacks, there have been great strides made in helping people survive initial acute cardiac events that were once considered a death sentence.' Other specific advancements noted in the study included: The invention in the 1960s of coronary artery bypass grafting and the formation of coronary care units improved in-hospital and long-term heart disease death rates. Cardiac imaging improved in the 1970s with coronary angiography, which was capitalized by the advent of balloon angioplasty in 1977, followed by coronary stenting to open blocked heart arteries in the 1980s to 1990s. Simultaneously, there was significant development of medical therapies in the 1970s to 1990s, including thrombolytics and aspirin to reduce blockages; beta blockers to treat high blood pressure; renal-angiotensin-aldosterone system inhibitors to slow the progression of heart and kidney disease; and statins to control cholesterol. These advances all contributed to the decline in deaths from treatment and deaths due to a second or subsequent acute cardiac event. At the turn of the 21st century, high-intensity statin therapy to lower cholesterol and dual antiplatelet therapy to reduce clotting were established, as well as landmark 'door-to-balloon' trials that displayed substantial benefits when care to open blocked arteries was expedited. From 2009 to 2022, high-sensitivity troponins that improved the rapid diagnosis of heart attacks and advanced antiplatelet agents to reduce clotting and restore blood flow to the heart further improved death rates, while lipid-lowering therapies such as ezetimibe and proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors emerged to improve options for secondary prevention. In addition to medical advances, significant public health strides, such as smoke-free policies, increased emphasis on physical activity and updated practice guidelines that support improved blood pressure and cholesterol management, have driven much of the improvements, according to the report. Study researchers point out that, despite overall reduction in heart disease and the progress in therapies and guidelines, there has been a substantial rise in many CVD risk factors, such as obesity, Type 2 diabetes, hypertension and physical inactivity, in the United States. An aging population is also contributing to an increase in the types of heart disease people are dying from. The report found: From the 1970s to 2022, obesity prevalence has risen from 15% to 40%. Type 2 diabetes including prediabetes, has risen to impact nearly half of all adults in the U.S. in 2020. Hypertension has increased from a prevalence of approximately 30% in 1978 to nearly 50% in 2022. Demographic shifts in the U.S. have also contributed significant changes to the landscape of heart disease mortality. From 1970 to 2022, there has been a notable increase in life expectancy, from 70.9 years to 77.5 years. 'All of these risk factors contribute to an ongoing burden of heart disease, especially as related to heart failure, hypertensive heart disease and arrhythmias,' said senior author of the paper Latha Palaniappan, M.D., M.S., FAHA, associate dean for research and a professor of medicine at Stanford University School of Medicine. 'While heart attack deaths are down by 90% since 1970, heart disease hasn't gone away. Now that people are surviving heart attacks, we are seeing a rise in other forms of heart disease like heart failure. The focus now must be on helping people age with strong, healthy hearts by preventing events, and prevention can start as early as childhood.' 'The American Heart Association has been a leader in both the medical advancements and the policy and guideline initiatives that have contributed to the reduction in overall heart disease deaths,' said Keith Churchwell, M.D., FAHA, the 2024-2025 American Heart Association volunteer president, an associate clinical professor of medicine at Yale School of Medicine in New Haven, Connecticut and an adjunct associate professor of Medicine at the Vanderbilt School of Medicine in Nashville, Tennessee. 'Through the nearly $6 billion dollars the Association has invested in scientific research since 1948, we have enhanced the knowledge of how we diagnose and treat heart disease in almost all forms. We have been a catalyst in collaborations with the public and private sectors in support of public health policies to improve the communities in which people live, work, learn and play. And we know, that by following the prescription of our Life's Essential 8(TM) health measures, we can prevent most heart disease and reduce deaths from heart disease by reducing the health risk factors that contribute to it.' The American Heart Association's Life's Essential 8 is a measure of cardiovascular health that includes eight essential components for ideal heart and brain health – 4 health behaviors and 4 health factors, including: Eat better. Be more active. Quit tobacco. Get healthy sleep. Manage weight. Control cholesterol. Manage blood sugar. Manage blood pressure. 'We've won major battles against heart attacks, however, the war against heart disease isn't over. We now need to tackle heart failure and other chronic conditions that affect people as they age,' King said. 'The cardiology community must prepare to meet this evolving burden through prevention, longitudinal management and multidisciplinary care that supports healthy aging. The next frontier in heart health must focus on preventing heart attacks, and also on helping people age with healthier hearts and avoiding chronic heart conditions later in life.' The authors note several limitations to this study: There is likely substantial differences in these reductions in heart disease deaths by age, sex, race, ethnicity, region and urbanization. The study did not analyze data including these components, and research including these factors should be prioritized in future studies to confirm if these overall trends remain valid in subpopulations. The use of multiple iterations of the International Classification of Diseases (ICD) coding system may allow for potential miscoding and presents challenges in maintaining consistency in comparisons across the years. Particularly prominent is the change from ICD-8 to ICD-9 in the year 1979, where the mortality of several conditions (valvular heart disease, hypertensive heart disease, pulmonary heart disease) dramatically increased. The true burden of ischemic heart disease may be underestimated in the findings presented in this study, since certain conditions including heart failure, cardiomyopathy, arrhythmias and in particular ventricular arrhythmias and cardiac arrest, may be overly simplistic. Many of these cases likely have underlying causes that cannot be precisely differentiated using current or past ICD codes. Co-authors, disclosures and funding sources are listed in the manuscript. Studies published in the American Heart Association's scientific journals are peer-reviewed. The statements and conclusions in each manuscript are solely those of the study authors and do not necessarily reflect the Association's policy or position. The Association makes no representation or guarantee as to their accuracy or reliability. The Association receives more than 85% of its revenue from sources other than corporations. These sources include contributions from individuals, foundations and estates, as well as investment earnings and revenue from the sale of our educational materials. Corporations (including pharmaceutical, device manufacturers and other companies) also make donations to the Association. The Association has strict policies to prevent any donations from influencing its science content. Overall financial information is available here . Additional Resources: ### About the American Heart Association The American Heart Association is a relentless force for a world of longer, healthier lives. Dedicated to ensuring equitable health in all communities, the organization has been a leading source of health information for more than one hundred years. Supported by more than 35 million volunteers globally, we fund groundbreaking research, advocate for the public's health, and provide critical resources to save and improve lives affected by cardiovascular disease and stroke. By driving breakthroughs and implementing proven solutions in science, policy, and care, we work tirelessly to advance health and transform lives every day. Connect with us on , Facebook , X or by calling 1-800-AHA-USA1. For Media Inquiries and AHA/ASA Expert Perspective: 214-706-1173 Cathy Lewis: [email protected] For Public Inquiries: 1-800-AHA-USA1 (242-8721) and
