Late-breaking data presented at the 2025 EAACI conference underscore the efficacy of Regeneron and Sanofi’s Dupixent in treating chronic rhinosinusitis with nasal polyps (CRSwNP) and asthma. The results from the pivotal Phase 4 EVEREST trial show that Dupixent outperformed Xolair across all primary and secondary efficacy endpoints for CRSwNP, as well as all asthma-related endpoints. This marks a critical milestone, representing the first head-to-head study comparing these biologic treatments in respiratory diseases.
The trial showcased Dupixent’s superiority in key symptom areas, including a significant reduction in nasal polyp size and improvements in the sense of smell in CRSwNP patients. In addition, the drug demonstrated noticeable enhancements in lung function and asthma control among asthma sufferers, with rapid improvements observable as early as four weeks into the study.
These findings further solidify the therapeutic value of Dupixent, which targets Interleukin-4 (IL-4) and Interleukin-13 (IL-13), key drivers of type 2 inflammation, in both upper and lower respiratory diseases.
TARRYTOWN, N.Y. and PARIS, June 15, 2025 – Regeneron Pharmaceuticals and Sanofi today unveiled positive outcomes from the EVEREST Phase 4 trial, involving adults with severe chronic rhinosinusitis with nasal polyps (CRSwNP) and coexisting asthma. The trial results demonstrated that Dupixent® (dupilumab) surpassed Xolair® (omalizumab) across all primary and secondary efficacy endpoints for CRSwNP and all asthma-related endpoints. Notably, this is the first trial to conduct a head-to-head evaluation of respiratory treatments that employ biologic medicines. The detailed data were shared in a late-breaking oral presentation at the 2025 European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress.
“Patients with chronic rhinosinusitis often contend with persistent nasal obstruction, leading to problematic nasal congestion and loss of smell. Compounding this, a considerable number of these individuals also have asthma, drastically affecting their quality of life,” stated Eugenio De Corso, M.D., Ph.D., an ENT Specialist specializing in Otolaryngology, Head and Neck Surgery, and Rhinology at the A. Gemelli University Hospital Foundation, IRCSS in Rome, Italy, and the lead investigator of the study. “EVEREST represents the initial trial to validate Dupixent’s superiority over Xolair using CRSwNP endpoints in patients with concurrent asthma, while also maintaining generally similar safety profiles. These Dupixent outcomes offer significant insights, assisting both patients and physicians in making informed treatment choices.”
The EVEREST trial included 360 adults experiencing severe, uncontrolled CRSwNP and concurrent asthma. Participants were randomized to receive either Dupixent 300 mg (n=181) every two weeks or Xolair (n=179), administered in a weight- and immunoglobulin E (IgE) level-based dosing regimen every two or four weeks. Both treatments were administered in conjunction with a background of mometasone furoate nasal spray (MFNS).
Key findings at 24 weeks for CRSwNP patients treated with Dupixent, compared to Xolair, with differences seen as early as 4 weeks:
- A 1.60-point superior reduction in reduction in nasal polyp size, a primary endpoint.
- An 8.0-point superior improvement in the ability to identify different smells, a primary endpoint. A larger number of Dupixent patients exhibited improvements above the anosmia threshold compared to those on Xolair.
- A 0.58-point superior reduction in nasal congestion/obstruction, a key secondary endpoint.
- A 0.81-point superior improvement in loss of smell, a key secondary endpoint.
- A 1.74-point superior reduction in symptom severity.
- A 12.7-point difference in health-related quality of life.
- A 31.27-point difference in peak nasal inspiratory flow.
- A 1.87-point difference in overall severity of rhinosinusitis.
Key findings at 24 weeks for asthma patients treated with Dupixent compared to Xolair, with differences seen as early as 4 weeks:
- A 150 mL difference in lung function (pre-bronchodilator FEV1).
- A 0.48-point difference in asthma control.
The safety profiles in the EVEREST trial generally aligned with Dupixent’s known safety profile in already approved respiratory indications. Overall adverse event (AE) rates were similar between Dupixent (64%) and Xolair (67%). Serious AEs occurred in 2% of Dupixent patients and 4% of Xolair patients. Additionally, AEs leading to trial discontinuation were reported in 3% of Dupixent patients and 1% of Xolair patients.
About the Dupixent Phase 4 Trial
EVEREST represents a randomized, double-blind Phase 4 trial designed to contrast the effectiveness and safety of Dupixent against Xolair in adults with severe, uncontrolled CRSwNP and coexisting mild, moderate, or severe asthma. Throughout the 24-week trial, patients received either Dupixent 300 mg every two weeks or Xolair, administered in a range from 75 to 600 mg every two or four weeks. Both treatment strategies were combined with a background of MFNS. Dosing for Xolair was determined according to each participant’s body weight and serum total IgE levels, following the approved label guidelines. All endpoints were evaluated at 24 weeks.
The primary endpoints included the alteration from baseline in the nasal polyp score (NPS), measured on a scale of 0-8, and in the University of Pennsylvania Smell Identification Test (UPSIT), based on a scale of 0-40. Secondary endpoints encompassed changes from baseline in nasal congestion (NC), quantified on a scale of 0-3, loss of smell (LoS), also on a scale of 0-3, and total symptom score (TSS), rated on a scale of 0-9. Additional measures involved the Sino-Nasal Outcome Test-22 (SNOT-22) on a scale of 0-110, peak nasal inspiratory flow, and the severity of rhinosinusitis disease, assessed via a visual analogue scale ranging from 0-10 cm. Furthermore, the study evaluated pre-bronchodilator forced expiratory volume in one second (pre-BD FEV1) and the 7-item Asthma Control Questionnaire (ACQ-7), scaled from 0-6.
About Dupixent
Dupixent, developed using Regeneron’s VelocImmune® technology, is a fully human monoclonal antibody that inhibits the signaling of the interleukin-4 (IL-4) and interleukin-13 (IL-13) pathways, and is not an immunosuppressant. The Dupixent development program has shown significant clinical benefit and a decrease in type 2 inflammation in Phase 3 trials, establishing that IL-4 and IL-13 are two of the key and central drivers of the type 2 inflammation that plays a major role in multiple related and often co-morbid diseases.
Dupixent has received regulatory approvals in more than 60 countries in one or more indications including certain patients with atopic dermatitis, asthma, CRSwNP, eosinophilic esophagitis (EoE), prurigo nodularis, chronic spontaneous urticaria (CSU) and chronic obstructive pulmonary disease (COPD) in different age populations. More than 1,000,000 patients are being treated with Dupixent globally.
About Regeneron’s VelocImmune Technology
Regeneron’s VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies.
U.S. INDICATIONS
DUPIXENT is a prescription medicine used:
- to treat adults and children 6 months of age and older with moderate-to-severe eczema (atopic dermatitis or AD) that is not well controlled with prescription therapies used on the skin (topical), or who cannot use topical therapies. DUPIXENT can be used with or without topical corticosteroids.
- with other asthma medicines for the maintenance treatment of moderate-to-severe eosinophilic or oral steroid dependent asthma in adults and children 6 years of age and older whose asthma is not controlled with their current asthma medicines.
- with other medicines for the maintenance treatment of chronic rhinosinusitis with nasal polyps (CRSwNP) in adults and children 12 years of age and older whose disease is not controlled.
- to treat adults and children 1 year of age and older with eosinophilic esophagitis (EoE), who weigh at least 33 pounds (15 kg).
- to treat adults with prurigo nodularis (PN).
- with other medicines for the maintenance treatment of adults with inadequately controlled chronic obstructive pulmonary disease (COPD) and a high number of blood eosinophils.
- to treat adults and children 12 years of age and older with chronic spontaneous urticaria (CSU) who continue to have hives that are not controlled with H1 antihistamine treatment.
DUPIXENT is not used to relieve sudden breathing problems and will not replace an inhaled rescue medicine.
DUPIXENT is not used to treat any other forms of hives (urticaria).
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to dupilumab or to any of the ingredients in DUPIXENT®.
Before using DUPIXENT, tell your healthcare provider about all your medical conditions, including if you:
- have eye problems.
- have a parasitic (helminth) infection.
- are scheduled to receive any vaccinations.
- are pregnant or plan to become pregnant.
- are breastfeeding or plan to breastfeed.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Especially tell your healthcare provider if you are taking oral, topical, or inhaled corticosteroid medicines; have asthma and use an asthma medicine; or have atopic dermatitis, chronic rhinosinusitis with nasal polyps, eosinophilic esophagitis, prurigo nodularis, chronic obstructive pulmonary disease, or chronic spontaneous urticaria, and also have asthma. Do not change or stop your other medicines, including corticosteroid medicine or other asthma medicine, without talking to your healthcare provider.
DUPIXENT can cause serious side effects, including:
- Allergic reactions.
- Eye problems.
- Inflammation of your blood vessels.
- Psoriasis.
- Joint aches and pain.
The most common side effects include:
- Eczema
- Asthma
- Chronic Rhinosinusitis with Nasal Polyps
- Eosinophilic Esophagitis
- Prurigo Nodularis
- Chronic Obstructive Pulmonary Disease
- Chronic Spontaneous Urticaria
Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Use DUPIXENT exactly as prescribed by your healthcare provider. Do not try to prepare and inject DUPIXENT until you or your caregiver have been trained by your healthcare provider.
Please see accompanying full Prescribing Information including Patient Information.
About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases.
About Sanofi
Sanofi is an R&D driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth.
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