Ebglyss

Ebglyss (lebrikizumab) is a prescription biologic injection used to treat moderate-to-severe atopic dermatitis (eczema) in patients 12 years and older who weigh at least 88 pounds (40 kg). It is prescribed when topical prescription treatments do not adequately control symptoms or when topical therapies are not suitable.

Ebglyss is an interleukin-13 (IL-13) antagonist, a type of monoclonal antibody that targets and blocks IL-13, a key protein that drives the chronic inflammation and skin barrier dysfunction seen in atopic eczema.

Ebglyss is given as a subcutaneous (under the skin) injection. After an initial loading period, patients move to a maintenance dose of either every 4 weeks or every 8 weeks, meaning some patients may need as few as 6 maintenance injections per year.

Ebglyss was granted FDA approval on September 13, 2024, for moderate-to-severe atopic dermatitis in patients 12 years and older, based on positive results from three clinical trials: ADvocate 1 (NCT04146363), ADvocate 2 (NCT04178967), and ADhere (NCT04250337).

Ebglyss works by blocking interleukin-13 (IL-13), a protein that drives the chronic inflammation and skin barrier dysfunction seen in atopic dermatitis.

People with atopic dermatitis produce high levels of a protein called interleukin-13 (IL-13), which drives the chronic inflammation, itching, dryness, and skin barrier dysfunction seen in eczema. In healthy skin, IL-13 levels are controlled, but in atopic dermatitis, the immune system overproduces IL-13, triggering a cycle of inflammation that damages the skin barrier and causes persistent symptoms.

Ebglyss contains lebrikizumab, a monoclonal antibody that binds directly to IL-13 and prevents it from attaching to its receptors on skin cells. By blocking IL-13 at the source, Ebglyss treats one of the underlying causes of eczema rather than just managing surface symptoms.

Yes, Ebglyss is a biologic, specifically a monoclonal antibody that targets a protein in the immune system. Ebglyss is one of four biologic monoclonal antibodies approved by the FDA for moderate-to-severe atopic dermatitis, alongside dupilumab (Dupixent), tralokinumab (Adbry), and nemolizumab (Nemluvio). These biologics work by targeting different proteins involved in atopic dermatitis inflammation — dupilumab blocks both IL-4 and IL-13, Ebglyss and tralokinumab specifically target IL-13, and nemolizumab targets IL-31. A healthcare provider can help determine which biologic is most appropriate based on individual patient factors.

Ebglyss has been shown to clear skin, relieve itch, and reduce eczema symptoms in clinical trials, with results significantly better than placebo at 16 weeks in both pivotal trials, ADvocate 1 and ADvocate 2.

Does Ebglyss clear skin?

Yes, Ebglyss clears or almost-clears skin in a significant proportion of patients at 16 weeks:

• ADvocate 1: 43% of Ebglyss patients achieved clear or almost-clear skin (IGA 0 or 1), compared to 13% on placebo
• ADvocate 2: 33% of Ebglyss patients achieved clear or almost-clear skin, compared to 11% on placebo

Does Ebglyss reduce eczema symptoms?

Yes, Ebglyss significantly reduces overall eczema symptoms across the body. In clinical trials, more than half of patients achieved a 75% or greater reduction in their overall eczema severity score (EASI-75) — measuring inflammation, redness, and affected body surface area — at 16 weeks:

• ADvocate 1: 59% of patients achieved EASI-75, compared to 16% on placebo
• ADvocate 2: 52% of patients achieved EASI-75, compared to 18% on placebo

In ADvocate 1, 38% of patients also achieved a 90% or greater reduction in eczema symptoms (EASI-90), compared to 9% on placebo.

Does Ebglyss relieve itch?

Yes, Ebglyss relieves itch in a significant proportion of patients, with some patients noticing improvement as early as Week 2:

• ADvocate 1: 46% of patients reported a meaningful reduction in itch at 16 weeks, compared to 13% on placebo
• ADvocate 2: 40% of patients reported meaningful itch reduction, compared to 12% on placebo

How long do Ebglyss results last?

Yes, Ebglyss results are durable over the long term across both every-4-week and every-8-week maintenance dosing. Of patients who responded at Week 16:

• Skin clearance: approximately 74–81% of patients who achieved clear or almost-clear skin maintained that response at one year
• Symptom reduction: approximately 77–85% of patients who achieved EASI-75 maintained that level of improvement at one year

How long does it take Ebglyss to work?

Ebglyss can start working as early as Week 2 for itch relief and Week 4 for skin clearance in some patients. Results continue to build over the 16-week treatment period, with the most significant improvements seen at Week 16.

Ebglyss instructions:

• Ebglyss is given as an injection under the skin (subcutaneous administration) using a prefilled pen or prefilled syringe with a needle shield.
• It is not necessary to allow the prefilled pen or prefilled syringe to warm up to room temperature before use.
• Injections may be given into the abdomen, thigh, and back of the upper arm. It may also be given in the back of the upper arm by a caregiver or healthcare provider.
• Alternate the injection site with each injection. Do not inject within 2 inches (5 cm) of the navel or into areas where the skin is tender, bruised, red, hard, or in an area of skin that is affected by atopic dermatitis or skin lesions.
• Ebglyss is intended for use under the guidance of a healthcare professional. Patients and caregivers should be properly trained in the subcutaneous injection technique to be used. Adult patients may self-inject, or caregivers may inject after training in subcutaneous injection technique. For pediatric patients, caregivers may give injections after training in subcutaneous injection technique.
• Injections should be inspected visually for particulate matter and discoloration before administration, whenever the solution and container permit. Ebglyss is clear to opalescent, colorless to slightly yellow to slightly brown solution. Do not use if the liquid contains visible particles, is discolored, or cloudy.
• Refer to the Instructions for Use for complete administration instructions with illustrations provided with the medicine.
• Before starting this medicine, complete all age-appropriate vaccinations according to current immunization guidelines.
• Ebglyss can be used with or without topical corticosteroids (TCS). Topical calcineurin inhibitors (TCI) may be used, but are reserved for sensitive areas only, such as the face, neck, intertriginous, and genital areas.

Do not use this medicine if you are allergic to the active ingredient lebrikizumab-lbkz or to any of the inactive ingredients in this medicine.

This medicine may cause hypersensitivity reactions, including swelling (angioedema) and hives (urticaria). Stop using this medicine if you have a serious hypersensitivity reaction.

This medicine can cause pink eye (conjunctivitis) and inflammation of the cornea (keratitis). Report new onset or worsening eye symptoms to a healthcare provider.

Before starting this medicine, treat patients with pre-existing worm (helminth) infections. If patients become infected while receiving this medicine and do not respond to anthelmintic treatment, stop treatment with Ebglyss until the infection resolves.

Avoid the use of live vaccines during treatment with this medicine.

Before using this medicine, tell your healthcare provider about all your medical conditions, including if you:

• Have a parasitic (helminth) infection.
• Are scheduled to receive any vaccinations. You should not receive a "live vaccine" if you are treated with this medicine.

Pregnancy

Tell your healthcare professional if you are pregnant, plan to become pregnant or become pregnant as it is not known if Ebglyss will harm your unborn baby. If you become pregnant during treatment with this medicine, you or your healthcare provider can call Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) to report the pregnancy.

Breastfeeding

Tell your healthcare professional if you are breastfeeding or plan to breastfeed. It is not known if this medicine passes into your breast milk.

Common Ebglyss side effects

The most common Ebglyss side effects include injection site reactions, eye and eyelid inflammation (conjunctivitis), dry eye, and shingles (herpes zoster). Conjunctivitis and dry eye are among the most frequently reported side effects and should be reported to a healthcare provider if they develop or worsen.

Serious Ebglyss side effects

Serious Ebglyss side effects may include:

Severe allergic reactions. Stop using Ebglyss and get emergency help right away if you experience:

• breathing problems or wheezing
• swelling of the face, lips, mouth, tongue, or throat
• fainting, dizziness, or feeling lightheaded
• hives or skin rash
• itching
• cramps in your stomach area (abdomen)

Eye problems. Tell your healthcare provider if you develop any new or worsening eye symptoms, including conjunctivitis (pink eye), eye pain, or changes in vision such as blurred vision.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

The cost of Ebglyss depends on whether you have insurance, your insurance plan type, if you have an Ebglyss Coupon or Savings Card, and which pharmacy you use.

The list price of Ebglyss is $3,675 per injection, but the amount you pay will largely depend on your prescription drug insurance plan.

You may pay as little as $5 for a 28-day supply of Ebglyss if it is covered by your commercial drug insurance plan and you enroll in the Ebglyss savings card program. If you have commercial insurance that does not cover Ebglyss, you may pay as little as $25 for 28 days supply.

Card savings are subject to a maximum monthly savings of wholesale acquisition cost plus usual and customary pharmacy charges and a separate maximum annual savings of up to$10,600 per calendar year.

The Ebglyss enrollment form is available from Lilly Support Services

See Ebglyss Terms and Conditions for eligibility requirements.

The recommended Ebglyss dosage is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg (one injection) every 2 weeks until Week 16 or later, when adequate clinical response is achieved. The maintenance dose is 250 mg every 4 weeks or 250 mg every 8 weeks, meaning some patients may need as few as 6 maintenance injections per year.

Ebglyss is available as:

• 250 mg/2 mL in a single-dose prefilled pen
• 250 mg/2 mL in a single-dose prefilled syringe with needle shield

If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.

In the event of overdosage, contact Poison Control (1-800-222-1222) for the latest recommendations and monitor the patient for any signs or symptoms of adverse reactions and institute appropriate symptomatic treatment immediately.

Other drugs may interact with this medicine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

HCPs and patients often use the Ebglyss Prescribing Information for more detailed information about this medicine. The Ebglyss Prescribing Information contains more comprehensive information on Indications and Usage, Dosage and Administration, Clinical Pharmacology, Clinical Studies, Drug Interaction, and more. Discuss any medical questions you have with your HCP (health care professional). This is not all the information you need to know about this medicine for safe and effective use, and it does not take the place of talking to your doctor about your treatment.

The Prescribing Information is sometimes called the Ebglyss Package Insert or FDA label.

Ebglyss should be stored refrigerated and protected from light. Key storage requirements include:

• Store refrigerated at 2°C to 8°C (36°F to 46°F).
• If necessary, pen or prefilled syringes can be stored in the original carton at room temperature up to 30°C (86°F) for up to 7 days. Dispose of medicine that has been left at room temperature for longer than 7 days.
• Store in the original carton to protect from light until use.
• Do not freeze. Do not use it if it has been frozen.
• Do not shake.
• Do not microwave, run hot water over it, or leave it in direct sunlight.

Active Ingredient: lebrikizumab-lbkz

Inactive ingredients: glacial acetic acid (1.8 mg), histidine (6.2 mg), polysorbate 20 (0.6 mg), sucrose (119.6 mg) and Water for Injection. The pH is 5.4 – 6.0.

Not made with natural rubber.