Itepekimab REGN3500 IL-33 asthma

Indicated For

asthma, COPD

About This Medication

# Itepekimab Patient Guide: How to Get Itepekimab at Low or No Cost **Important Notice:** As of March 2026, itepekimab (SAR440340/REGN3500) is an investigational monoclonal antibody developed by Regeneron Pharmaceuticals, Inc. and Sanofi for conditions like **chronic obstructive pulmonary disease (COPD)** and **chronic rhinosinusitis with nasal polyps (CRSwNP)**. It is not yet FDA-approved, and no commercial patient assistance program exists.[1][2][3] This guide provides general information on accessing itepekimab through clinical trials or potential future programs, along with standard steps for manufacturer assistance programs. ## About Itepekimab Itepekimab is a fully human monoclonal antibody that targets and inhibits **interleukin-33 (IL-33)**, a protein that drives inflammation in respiratory diseases. By blocking IL-33, itepekimab aims to reduce airway inflammation, exacerbations, and symptoms like nasal polyps, congestion, and lung function decline.[1][3][6] - **For COPD:** In trials like AERIFY-1 (NCT04701983), itepekimab is tested in former smokers with moderate-to-severe COPD to lower the rate of moderate-or-severe exacerbations, improve FEV1 (lung function), respiratory symptoms, and quality of life via tools like the St. George's Respiratory Questionnaire (SGRQ).[1] - **For CRSwNP:** Phase 3 trials (e.g., EFC18418/NCT06834347, EFC18419) evaluate it as add-on therapy to nasal corticosteroids, measuring reductions in polyp size, nasal congestion, and sinus inflammation over 52 weeks.[2][3] Itepekimab is administered subcutaneously (under the skin), often via prefilled syringe or autoinjector, with studies showing comparable pharmacokinetics.[5] Safety, tolerability, and immunogenicity are ongoing evaluation points.[1] Since it's investigational, patients access it primarily through **clinical trials**. Visit ClinicalTrials.gov and search 'itepekimab' for active studies near you.[1][2] ## Who Qualifies for Access? No commercial assistance program is available yet. Eligibility focuses on clinical trial criteria: - **COPD trials:** Former smokers, moderate-to-severe COPD, history of exacerbations.[1] - **CRSwNP trials:** Adults 18+ with inadequately controlled symptoms despite nasal steroids.[2][3] Future commercial programs (post-approval) from Regeneron/Sanofi typically target: - Uninsured or underinsured patients. - US residents (often). - Specific medical diagnoses. ## Income Eligibility Breakdown No specific income thresholds are published for itepekimab, as no program exists. Regeneron/Sanofi programs for similar drugs (e.g., Dupixent for COPD) often use **400-800% of the Federal Poverty Level (FPL)**.[4] Here's a general table for reference (2026 FPL estimates; check HHS.gov for exact figures): | Household Size | 400% FPL | 500% FPL | 600% FPL | 800% FPL | |----------------|----------|----------|----------|----------| | Individual | ~$60,000 | ~$75,000 | ~$90,000 | ~$120,000| | Couple | ~$80,000 | ~$100,000| ~$120,000| ~$160,000| | Family of 3 | ~$100,000| ~$125,000| ~$150,000| ~$200,000| | Family of 4 | ~$120,000| ~$150,000| ~$180,000| ~$240,000| *Notes:* Thresholds vary; higher incomes may qualify if insured with high copays. Always verify with manufacturer.[4] ## Insurance Requirements For investigational drugs, insurance rarely covers; trials provide free medication. Post-approval: - Often requires **commercial insurance** or **Medicare Part D** (may exclude low-income). - Government insurance (Medicaid, Medicare low-income subsidy) typically ineligible. - Uninsured patients prioritized. Contact Regeneron/Sanofi for expanded access if trials unavailable. ## Step-by-Step Application Process **For Clinical Trials (Current Option):** 1. Search ClinicalTrials.gov for 'itepekimab' (e.g., NCT04701983, NCT06834347).[1][2] 2. Check eligibility (age, diagnosis, smoking history). 3. Contact trial sites (e.g., UChicago Medicine, Cedars-Sinai).[2][3] 4. Complete screening (4 weeks typical).[2] 5. If enrolled, receive free drug for trial duration (52-76 weeks).[1][2] **For Future Commercial Program (Hypothetical, Based on Similar Programs):** 1. Visit Regeneron/Sanofi websites or call 1-888-4-ASSIST (generic example). 2. Download application or apply online. 3. Provide diagnosis from doctor, proof of income (tax returns, paystubs), insurance details. 4. Doctor submits prescription. 5. Approval notification in 1-2 weeks. ## Timeline and Delivery - **Trial Enrollment:** Screening 4 weeks, treatment 52 weeks, follow-up 20 weeks.[1][2] - **Commercial (Estimated):** Processing 5-10 business days; medication shipped to doctor's office or home via specialty pharmacy. - **Refills:** Auto-ship or annual renewal. ## Alternatives if Denied or Ineligible - **Other Trials:** Search for IL-33 inhibitors or COPD/CRSwNP studies. - **Approved Biologics:** For COPD, **Dupixent (dupilumab)** by Regeneron/Sanofi (FDA-approved 2024 for eosinophilic COPD).[4] Access via Dupixent MyWay program. - **General Help:** NeedyMeds.org, RxAssist.org, Partnership for Prescription Assistance. - **Biosimilars:** None available yet.[4] ## Disclaimer This guide is for informational purposes only and not medical advice. Itepekimab is experimental; discuss risks/benefits with your doctor. Program details may change upon approval. Consult Regeneron (regeneron.com) or Sanofi (sanofi.us) directly. No warranties provided. (Word count: 912)

Program information last verified: March 30, 2026