EBGLYSS now stands as the sole approved therapy providing as few as six maintenance injections annually without any required topical treatments from the outset.

Eli Lilly and Company announced that the U.S. Food and Drug Administration approved a regimen of one maintenance dose every eight weeks consisting of a single 250 mg injection of EBGLYSS for subcutaneous administration in adults and children aged 12 years and older weighing at least 88 pounds with moderate-to-severe atopic dermatitis. The product already holds approval for monthly maintenance dosing backed by long-term evidence of sustained control. This update allows patients to address their condition with as few as six maintenance injections each year.

The expanded approval strengthens the established durability profile of EBGLYSS by adding an every-eight-weeks option. Individuals managing moderate-to-severe atopic dermatitis can now use a therapy needed only six times yearly without prescription topicals required initially, noted Adrienne Brown, executive vice president and president of Lilly Immunology. EBGLYSS enables patients to experience fewer flares and fewer disruptions to daily life from atopic dermatitis.

Supporting data came from longitudinal exposure-response modeling along with every-eight-weeks results from an extension of the Phase 3 ADjoin long-term study that assessed maintenance dosing every four or eight weeks across 32 weeks.

Extending EBGLYSS maintenance dosing to every eight weeks marks a key development for those living with moderate-to-severe atopic dermatitis, stated Peter Lio, M.D., ADjoin study author and clinical assistant professor of dermatology and pediatrics at Northwestern University. The regimen without mandatory topicals lets patients tailor management to personal circumstances and meet them where they are.

No fresh safety concerns emerged in the 32-week ADjoin every-eight-weeks extension data. No discontinuations occurred due to adverse events through that period. The most frequent adverse reactions reported remain conjunctivitis, injection site reactions, and herpes zoster.

Moderate-to-severe atopic dermatitis often involves recurring symptoms and demanding treatment schedules during and between flares, observed Kristin Belleson, president and CEO of the National Eczema Association. Patients seek options delivering lasting control and reduced injection frequency. This new choice can lessen the load and free more time from daily condition management.

Lilly holds exclusive development and commercialization rights for EBGLYSS in the United States and worldwide outside Europe. Almirall licensed rights for dermatology indications including atopic dermatitis within Europe.

The Q8W ADjoin extension evaluated EBGLYSS given once every eight weeks or every four weeks for long-term safety and efficacy over 32 weeks in patients with moderate-to-severe atopic dermatitis. Eligible participants included adults and adolescents aged 12 to 17 weighing at least 40 kg who finished the 100-week ADjoin study originating from trials such as ADvocate 1 and 2, ADore, and ADopt-VA. Patients received open-label 250 mg EBGLYSS every eight or four weeks irrespective of prior dosing or response. The approved maintenance schedule is 250 mg every four weeks or every eight weeks following an initial every-two-weeks period of 16 weeks or once adequate response occurs.

EBGLYSS is a monoclonal antibody that selectively targets and neutralizes IL-13 with high affinity and slow dissociation. It binds the cytokine at a site overlapping the IL-4Rα subunit, blocking receptor complex formation and inhibiting signaling. IL-13 drives the type-2 inflammatory cycle in skin and represents a primary cytokine in atopic dermatitis pathophysiology.

The Phase 3 program encompasses seven global studies involving more than 1,600 patients, covering monotherapy trials, a combination study with topical corticosteroids, long-term extension, adolescent open-label work, vaccine response assessment, skin-of-color evaluation, and dupilumab-experienced patient study. EBGLYSS received approval in the United States, Japan, and Canada in 2024 and the European Union in 2023. It serves as first-line biologic therapy usable with or without topical corticosteroids for adults and children 12 years and older weighing at least 88 pounds whose moderate-to-severe atopic dermatitis remains inadequately controlled by topical prescription therapies. The recommended starting regimen is 500 mg at Week 0 and Week 2, then 250 mg every two weeks until Week 16 or later once adequate response is reached, followed by maintenance of 250 mg every four or eight weeks.

Lilly continues efforts to broaden first-line biologic access for patients not controlled by topical prescription therapy through commercial insurance. Coverage exists with all three major national pharmacy benefit managers, reaching 94 percent of commercially insured lives via national plans. Medicaid access has expanded while Medicare coverage pursuits advance under health equity and affordability goals. Lilly Support Services for EBGLYSS includes co-pay assistance for qualifying commercially insured patients.

EBGLYSS is an injectable treatment for adults and children 12 years and older weighing at least 88 pounds with moderate-to-severe eczema not adequately managed by topical prescription therapies or when such therapies cannot be used. It may be administered with or without topical corticosteroids. Safety and effectiveness remain unestablished in children younger than 12 years or in those 12 to under 18 years weighing less than 88 pounds.

Do not use EBGLYSS if allergic to lebrikizumab-lbkz or any ingredient. Prior to starting, inform the healthcare provider of any parasitic infection, upcoming vaccinations (live vaccines should be avoided), pregnancy or plans to become pregnant, and breastfeeding intentions. Disclose all medicines taken including prescriptions, over-the-counter products, vitamins, and supplements.

EBGLYSS may cause serious side effects including allergic reactions that can be severe. Stop use and seek immediate help for breathing difficulty, facial swelling, hives, itching, fainting, dizziness, rash, or abdominal cramps. Report any new or worsening eye problems such as pain or vision changes. Common side effects include eye and eyelid inflammation, injection site reactions, and shingles.

These points do not cover all possible effects. Consult a doctor for medical advice and report side effects to the FDA. Full instructions for use accompany the product for preparation, injection, storage, and disposal. Use exactly as prescribed. Injections are given under the skin. Training is required before self-administration or caregiver use. Children 12 years and older should receive injections from a caregiver. Missed doses should be taken as soon as possible with the next dose on schedule.

EBGLYSS is supplied as a 250 mg/2 mL prefilled pen or syringe. Additional details are available by calling 1-800-545-5979 or visiting the product website. This overview supplies basic information and does not replace full prescribing details or physician consultation. The prescribing doctor remains the best resource for determining suitability.