FDA Approves Lebrikizumab 8-Week Maintenance Dosing in Atopic Dermatitis

The US Food and Drug Administration (FDA) has approved a maintenance regimen of lebrikizumab (Ebglyss) 250 mg administered once every 8 weeks for adults and children aged 12 years and older weighing at least 40 kg with moderate to severe atopic dermatitis, Eli Lilly and Company announced on June 9, 2026.¹

Lebrikizumab, an interleukin-13 (IL-13) inhibitor, received initial US approval in 2024 as a first-line biologic with once-monthly maintenance dosing and, more recently, long-term data have shown durable disease control with the agent through up to 4 years of continuous treatment.^2,3 The every-8-week option reduces injection frequency for patients maintaining adequate clinical response.¹

"The option to extend EBGLYSS maintenance dosing to every eight weeks represents an important moment for patients living with moderate-to-severe atopic dermatitis," said Peter Lio, MD, primary investigator of the ADjoin study and clinical assistant professor of dermatology and pediatrics, Northwestern University. "This new dosing regimen without mandatory topicals gives patients a new option to manage their condition based on individual needs. It's about meeting patients where they are in their lives."

Lebrikizumab every-8-week dosing data from the ADjoin extension

The approval rests on longitudinal exposure-response modeling and clinical data from a 32-week extension of the phase 3 ADjoin long-term trial (NCT04392154). The extension evaluated open-label lebrikizumab 250 mg administered once every 8 weeks or once every 4 weeks in adult patients and adolescents aged 12 to 17 years weighing at least 40 kg with moderate to severe disease across select countries.²

Eligible participants had completed the 100-week ADjoin long-term study, with enrollment drawn from the phase 3 ADvocate 1 and ADvocate 2 monotherapy trials, the ADore adolescent open-label study, and the ADopt-VA vaccine response study. Patients received the every-8-week or every-4-week dose regardless of their previous ADjoin regimen or response status at extension baseline.²

Under the updated label, maintenance dosing of 250 mg every 4 weeks or every 8 weeks begins after an induction period of 250 mg every 2 weeks through week 16, or later once adequate clinical response is achieved.¹

Lebrikizumab safety profile through 32 weeks of extended dosing

No new safety signals emerged in lebrikizumab safety data from the 32-week every-8-week ADjoin extension, according to Lilly. No patients discontinued treatment due to adverse events through 32 weeks.The most common adverse reactions reported with lebrikizumab, occurring in at least 1% of patients, are conjunctivitis, injection site reactions, and herpes zoster.¹

According to the company, lebrikizumab is now the only approved option in this indication offering as few as 6 maintenance injections per year, with no required topical therapy from treatment initiation.¹

"Living with moderate-to-severe atopic dermatitis often means dealing with a cycle of symptoms and time-intensive treatment routines during and in-between flares," said Kristin Belleson, president and CEO of the National Eczema Association. "This new option can ease the burden, allowing patients to spend less time thinking about managing their condition on a daily basis."

Lilly reported coverage with all 3 major national pharmacy benefit managers, with 94% of commercially insured patients covered through national health plans. The company is pursuing expanded Medicaid and Medicare coverage and offers co-pay assistance for eligible, commercially insured patients through Lilly Support Services.¹

References

1. Eli Lilly and Company. FDA approves Lilly's EBGLYSS (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis. Press release. Published June 9, 2026. Accessed June 10, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglyssr-lebrikizumab-lbkz-one-maintenance

2. Silverberg J, et al. Lebrikizumab every 8 weeks as maintenance dose provides long-lasting response in patients with moderate-to-severe atopic dermatitis. Presented at: Fall Clinical Dermatology Conference; 2025.

3. HCPLive. Lebrikizumab for Atopic Dermatitis Leads to 4 Years of Clearance, Itch Reduction. https://www.hcplive.com/view/lebrikizumab-atopic-dermatitis-leads-4-years-clearance-itch-reduction. Published April 2, 2026. Accessed June 10, 2026.