Top 5 Biologics for EoE Treatment
By Dante Holloway | Published: 2025-03-31 | Category: Biologics For Eoe
About Biologics For Eoe
Biologics for Eosinophilic Esophagitis (EoE) are advanced medications, often monoclonal antibodies, targeting specific inflammatory pathways driving the disease. They represent a targeted approach compared to broader therapies like corticosteroids.
How We Tested
Products were evaluated based on clinical trial data efficacy for EoE, safety profiles, FDA approval status specifically for EoE, mechanism of action, and administration method. Evaluation relies on publicly available clinical research and regulatory filings.
Scoring Criteria
- → Clinical Efficacy (EoE)
- → Safety Profile
- → FDA Approval Status (EoE)
- → Mechanism of Action Specificity
- → Administration Route/Frequency
The Best Biologics For Eoe
Cinqair
By Teva Pharmaceutical Industries Ltd.
Monoclonal antibody targeting IL-5. Studied for EoE, approved for severe eosinophilic asthma in adults. Requires intravenous (IV) infusion.
Key Features
- ✓Target: Interleukin-5 (IL-5)
- ✓Administration: Intravenous (IV) infusion
- ✓EoE Approval (US): No (Investigational for EoE)
- ✓Frequency (Asthma): Every 4 weeks
- ✓Manufacturer Address (Israel HQ): 124 Dvora HaNevia St, Tel Aviv-Yafo, 6944020, Israel
- ✓Website: https://www.cinqair.com
Scorecard (Overall: 2.2 / 5.0)
Pros
- + Targets IL-5, contributing to reduced eosinophil levels.
- + Approved indication for severe eosinophilic asthma in adults.
- + IV administration ensures complete bioavailability.
Cons
- - Not FDA-approved for the treatment of EoE.
- - Requires administration via IV infusion in a healthcare setting, which is inconvenient.
- - Carries a boxed warning for potential serious allergic reactions (anaphylaxis).
- - Less practical compared to subcutaneous options for chronic EoE management.
Verdict
"An IV-administered IL-5 inhibitor approved for asthma and studied in EoE, but its inconvenient administration route and lack of specific EoE approval limit its applicability."
Tezspire
By Amgen / AstraZeneca
Monoclonal antibody targeting Thymic Stromal Lymphopoietin (TSLP), an upstream epithelial cytokine involved in multiple inflammatory pathways. Studied for EoE, approved for severe asthma.
Key Features
- ✓Target: Thymic Stromal Lymphopoietin (TSLP)
- ✓Administration: Subcutaneous injection
- ✓EoE Approval (US): No (Investigational for EoE)
- ✓Frequency (Asthma): Every 4 weeks
- ✓Manufacturer Address (Amgen HQ): One Amgen Center Drive, Thousand Oaks, CA 91320-1799, USA
- ✓Website: https://www.tezspire.com
Scorecard (Overall: 3.0 / 5.0)
Pros
- + Targets TSLP, acting high up in the inflammatory cascade potentially affecting broader aspects of Type 2 inflammation beyond eosinophils.
- + Approved for severe asthma without requiring a specific phenotype (like eosinophilic).
- + Early studies suggest potential for histological improvement in EoE.
Cons
- - Not FDA-approved for the treatment of EoE.
- - Clinical data specifically for EoE is still emerging and limited compared to other biologics.
- - Requires monthly subcutaneous injections; common side effects include pharyngitis, arthralgia, and back pain.
Verdict
"A novel biologic targeting TSLP with broad anti-inflammatory potential, approved for severe asthma and currently under investigation for EoE."
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Nucala
By GSK (GlaxoSmithKline plc)
Monoclonal antibody targeting IL-5, reducing eosinophil production and survival. Studied for EoE, approved for severe eosinophilic asthma, EGPA, HES, and CRSwNP.
Key Features
- ✓Target: Interleukin-5 (IL-5)
- ✓Administration: Subcutaneous injection
- ✓EoE Approval (US): No (Investigational for EoE)
- ✓Frequency (Asthma/EoE studies): Every 4 weeks
- ✓Manufacturer Address (UK HQ): 980 Great West Road, Brentford, Middlesex, TW8 9GS, UK
- ✓Website: https://www.nucala.com
Scorecard (Overall: 3.0 / 5.0)
Pros
- + Targets IL-5, a key cytokine driving eosinophil activity.
- + Approved and established efficacy/safety profile in multiple eosinophil-driven diseases.
- + Demonstrated reduction in esophageal eosinophil counts in EoE clinical trials.
Cons
- - Not FDA-approved for the treatment of EoE.
- - Clinical trial data showed histological improvement but sometimes limited or inconsistent symptomatic benefit in EoE patients.
- - Requires monthly subcutaneous injections; potential side effects include headache, injection site reactions, back pain, and fatigue.
Verdict
"An IL-5 inhibitor effective in various eosinophilic conditions and studied in EoE, showing histological promise but lacking specific approval and consistent symptomatic data for EoE."
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Fasenra
By AstraZeneca
Monoclonal antibody targeting the IL-5 receptor alpha (IL-5Rα), depleting eosinophils. Studied for EoE, approved for severe eosinophilic asthma.
Key Features
- ✓Target: IL-5 Receptor Alpha (IL-5Rα)
- ✓Administration: Subcutaneous injection
- ✓EoE Approval (US): No (Investigational for EoE)
- ✓Frequency (Asthma): Every 4 weeks for 3 doses, then every 8 weeks
- ✓Manufacturer Address (UK HQ): 1 Francis Crick Avenue, Cambridge Biomedical Campus, Cambridge, CB2 0AA, UK
- ✓Website: https://www.fasenra.com
Scorecard (Overall: 3.0 / 5.0)
Pros
- + Directly targets and rapidly depletes eosinophils.
- + Established safety profile from extensive use in severe eosinophilic asthma.
- + Less frequent maintenance dosing (every 8 weeks) in its approved indication.
Cons
- - Not FDA-approved for the treatment of EoE.
- - Clinical trial results for EoE have shown mixed results regarding symptom improvement despite histological effects.
- - Requires subcutaneous injection; potential side effects include headache, pharyngitis, and injection site reactions.
Verdict
"A potent eosinophil-depleting biologic, effective for severe asthma and studied in EoE, but currently lacks FDA approval for this specific indication."
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Dupixent
By Sanofi / Regeneron Pharmaceuticals, Inc.
Monoclonal antibody targeting IL-4 and IL-13 pathways, FDA-approved for EoE in adults and pediatric patients (1+ years, ≥15 kg).
Key Features
- ✓Target: IL-4 Receptor Alpha (inhibits IL-4 & IL-13 signaling)
- ✓Administration: Subcutaneous injection
- ✓EoE Approval (US): Yes (Adults & Pediatric patients aged 1 year+, ≥15 kg)
- ✓Frequency: 300mg weekly
- ✓Manufacturer Address (Regeneron HQ): 777 Old Saw Mill River Road, Tarrytown, NY 10591, USA
- ✓Website: https://www.dupixent.com
Scorecard (Overall: 4.2 / 5.0)
Pros
- + First and only FDA-approved biologic specifically for EoE treatment.
- + Demonstrated high efficacy in reducing esophageal eosinophils and improving dysphagia symptoms in clinical trials.
- + Targets key cytokines (IL-4, IL-13) central to Type 2 inflammation involved in EoE pathogenesis.
Cons
- - Requires regular subcutaneous injections.
- - Potential side effects include injection site reactions, upper respiratory tract infections, arthralgia, and herpes viral infections.
- - High cost, requiring insurance coverage and prior authorization typically.
Verdict
"The leading and sole FDA-approved biologic therapy for EoE, offering significant histological and symptomatic improvement for appropriate patients."
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Final Thoughts
Dupixent stands alone as the only FDA-approved biologic specifically for treating Eosinophilic Esophagitis, demonstrating significant efficacy. Other biologics like Fasenra, Nucala, Tezspire, and Cinqair, primarily approved for severe asthma or other eosinophilic conditions, have been investigated for EoE with varying degrees of success but currently lack regulatory approval for this indication. The choice of therapy depends heavily on approval status, individual patient factors, and specialist consultation.
Notable Mentions:
- Fasenra (benralizumab): Potent eosinophil depletion via IL-5Rα targeting, studied in EoE.
- Nucala (mepolizumab): Established IL-5 inhibitor used in multiple eosinophilic diseases, studied in EoE.
- Tezspire (tezepelumab): Novel mechanism targeting upstream TSLP, under investigation for EoE.
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