Dupixent for EoE: First FDA-approved treatment for adults & children

Dupixent is an injectable prescription drug containing the active ingredient dupilumab made by Sanofi-Aventis and Regeneron Pharmaceuticals. In January 2024, it became the first and only treatment approved by the Food and Drug Administration (FDA) for eosinophilic esophagitis (EoE) in children ages 1 and older. 

EoE is a chronic (ongoing) disease of the esophagus, the tube that carries food and liquids from the mouth to the stomach. People with EoE have a buildup of eosinophils (a type of white blood cell) in the esophagus, which causes damage and inflammation. Symptoms include pain, difficulty swallowing, and getting food stuck in the throat. 

Dupixent is a monoclonal antibody and is classified as an interleukin-4 receptor alpha antagonist. It works by stopping the action of substances in the body that cause inflammation. Dupixent is approved by the FDA to treat:

• Eosinophilic esophagitis in adults and children ages 1 and older, weighing at least 33 pounds
• Moderate-to-severe atopic dermatitis (the most common type of eczema) in adults and children ages 6 months and older
• In adults and children 6 years and older, moderate to severe asthma characterized by an eosinophilic phenotype (a severe type of asthma associated with a large number of eosinophils) or asthma that is dependent on oral steroid medications
• Chronic rhinosinusitis with nasal polyps (a condition characterized by sinus problems, stuffy nose, and growths in the nose or sinuses) in adults
• Prurigo nodularis (a skin disorder characterized by hard, itchy bumps called nodules) in adults

Dupixent as a treatment for eosinophilic esophagitis (EoE)

Currently, there is no cure for EoE, but there are ways to treat its symptoms, including:

• Dietary modifications
• Procedures such as esophageal dilation
• Medications such as corticosteroids, proton pump inhibitors, and biologics (such as Dupixent)

Dupixent works by interfering with the process of inflammation associated with EoE. The injectable medication was originally FDA approved in May 2022 for EoE treatment in adults and children ages 12 years and older. In January 2024, the FDA expanded this indication to include pediatric patients ages 1 to 11 years weighing at least 33 pounds, which is the first treatment of EoE in this age group.

This expanded approval is based on the results of the joint manufacturers’ Phase 3 EoE KIDS trial. The trial examined the efficacy and safety of Dupixent in children under 12 years old and found that 66% of children who received a higher dose of Dupixent went into remission, compared with 3% of children who received placebo (inactive medicine). Of the children who went into remission, 53% stayed in remission at week 52. Additionally, children who took Dupixent experienced fewer days of EoE symptoms compared with those who took a placebo. The safety profile for younger children was similar to that of patients older than 12. The most common side effects were injection site reactions, upper respiratory tract infections, joint pain, and herpes viral infections.

Before this expanded approval in younger patients, other studies found Dupixent to be a safe and effective treatment for EoE. For example, a study published in the New England Journal of Medicine found that people who took Dupixent reported improved symptoms of EoE, and improvements could be seen in terms of lower eosinophil counts (histologic remission).

Dupixent dosage for EoE

Dupixent is injected subcutaneously (under the skin) into the thigh or abdomen if done by the patient. If a trained caregiver administers the injection, it can be injected into the thigh, abdomen, or upper arm. Healthcare providers train patients and caregivers to prepare and inject the medication in advance.

The dosage of Dupixent for adults and children ages 1 and older (who weigh 33 pounds or more) for EOE is as follows:

• For individuals weighing 33 pounds to less than 66 pounds, the dosage is 200 mg every other week.
• For individuals weighing 66 pounds to less than 88 pounds, the dosage is 300 mg every other week.
• For individuals weighing 88 pounds or more, the dosage is 300 milligrams (mg) weekly.

It is important to rotate injection sites: Don’t use the same site two times in a row, and don’t inject Dupixent into skin that is tender, bruised, damaged, or scarred.

If you need additional support and supplemental injection training on Dupixent injections, you can contact a registered nurse at Dupixent MyWay Nurse Educators at 844-DUPIXENT

(844-387-4936), option 1, Monday through Friday, 8 a.m. to 9 p.m. ET.

Dupixent side effects & warnings

Some of the most common Dupixent side effects include:

• Injection site reactions (redness or pain at the site of the injection)
• Sore throat, runny nose, cough, fever, or other infection symptoms
• Mouth sores and lip sores
• Toothache 
• Insomnia (difficulty falling or staying asleep)
• Redness or rash on the face
• Dizziness
• Muscle pain
• Diarrhea 

Certain serious side effects require emergency medical help, including:

• Hives, difficulty breathing or swallowing, or swelling of the face, lips, tongue, or throat—all symptoms of an allergic reaction
• Eye problems, including pain, changes in vision or blurry vision, pink or red eyes, or red or inflamed eyelids
• New or worsening joint pain
• Swollen lymph nodes
• Rapid heartbeat
• Stomach problems, including cramps, nausea, or vomiting
• Fever 
• Skin lumps that are flat, firm, red, hot, and painful

Follow your healthcare provider’s medical advice for decreasing your dose of oral or topical corticosteroids, if recommended. Report any new or worsening eye symptoms to your healthcare provider. Be especially alert to symptoms such as rash, breathing problems, numbness, and tingling when lowering the dose of oral steroids.

Check with your healthcare provider before getting any vaccines while taking Dupixent, and avoid live vaccines during treatment. Some examples of live vaccines include the measles, mumps, and rubella (MMR) vaccine, varicella, rotavirus, and nasal flu vaccine. Any helminth (parasite) infections should be treated before you start taking Dupixent. 

Who should not take Dupixent for EOE?

You should not take Dupixent if you are allergic to dupilumab or any ingredient in the medication. Dupixent also should not be used for acute bronchospasm (when the airways become constricted, making it hard to breathe) or status asthmaticus (a medical emergency of severe asthma symptoms that do not respond to treatment). 

How much does Dupixent cost?

The average retail price of Dupixent is $5,037.88 for two 2 mL syringes or pens. According to the Dupixent website, about 60% of people with insurance will pay $100 or less monthly for Dupixent, while 40% will pay $100 or more monthly. Insured patients eligible for the Dupixent MyWay Copay Card may get Dupixent for free, with a maximum annual savings of $13,000. 

According to the manufacturer of Dupixent, about 79% of Medicare beneficiaries with prescription coverage pay $100 or less per month, and most people with Medicaid coverage pay less than $9 a month for their prescription. Keep in mind that your final out-of-pocket cost depends on the details of your plan. Some people with Medicare Part D are eligible for the Extra Help program, which could lower their costs significantly. 

Regardless of insurance status, you can also call 1-844-DUPIXENT and speak with a Dupixent MyWay representative to learn about other types of financial assistance.

Another option is to use a free SingleCare prescription discount card or coupon to help pay for Dupixent. While the cost of Dupixent without insurance is close to $5,040, you can use a SingleCare Dupixent coupon to pay as low as $3,610 for two pens or syringes.