Lebrikizumab Earns FDA Approval for Less Frequent, Every-8-Week Maintenance Dosing in AD

The US Food and Drug Administration (FDA) has approved an every-8-week maintenance dosing regimen for lebrikizumab-lbkz (EBGLYSS) in adults and adolescents aged 12 years and older who weigh at least 40 kg and have moderate to severe atopic dermatitis (AD).¹ The approval expands dosing options for patients receiving the IL-13-targeting biologic, which was previously approved with a once-monthly maintenance schedule. With the new regimen, eligible patients may maintain disease control with as few as 6 maintenance injections per year following the initial treatment period.

Supporting Data from the ADjoin Extension

The approval was supported by longitudinal exposure-response modeling and clinical data from the every-8-week (Q8W) extension of the phase 3 ADjoin long-term study.² Eligible participants included those who had previously participated in the phase 3 ADvocate 1 and ADvocate 2 trials, the ADore adolescent study, and the ADopt-VA study. The extension evaluated maintenance dosing of open-label lebrikizumab 250 mg every 4 weeks (Q4W) or every 8 weeks over a 32-week period, regardless of their prior dosing schedule or treatment response at the start of the extension.

No new safety signals were identified during the 32-week extension period. In addition, no patients discontinued treatment because of adverse events. The most commonly reported adverse reactions, occurring in at least 1% of patients, were conjunctivitis, injection-site reactions, and herpes zoster.

Expanding Long-Term Treatment Options

Lebrikizumab, originally approved by the FDA in 2024, is a monoclonal antibody designed to selectively target and neutralize interleukin (IL)-13. The therapy binds to IL-13 with high affinity and prevents formation of the IL-13 receptor complex, thereby inhibiting IL-13 signaling.

The FDA-approved dosing regimen begins with a 500-mg loading dose administered as two 250-mg injections at weeks 0 and 2. Patients then receive 250 mg every 2 weeks through week 16, or later until an adequate clinical response is achieved. Following that induction period, maintenance treatment may be administered every 4 weeks or every 8 weeks.

MORE ON ATOPIC DERMATITIS

The phase 3 clinical development program for lebrikizumab in AD has included more than 1,600 patients across 7 key global studies. These studies have evaluated the therapy as monotherapy, in combination with topical corticosteroids, in adolescents, in patients with skin of color, and in patients previously treated with dupilumab.

Expert Insights

"Today's approval builds on EBGLYSS' established long-term durability, with a new option for one maintenance dose every 8 weeks. For people living with moderate to severe atopic dermatitis, that means a treatment they only need to take as few as 6 times a year—without prescription topicals from the start," Adrienne Brown, executive vice president and president of Lilly Immunology, said in the press release. "EBGLYSS now gives patients the opportunity to flare less and live their lives with fewer interruptions from atopic dermatitis."¹

Peter Lio, MD, a clinical assistant professor of dermatology and pediatrics at Northwestern University and an author of the ADjoin study, described the approval as an “important moment” for patients managing chronic disease. "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."¹

Christopher G. Bunick, MD, PhD, editor in chief of Dermatology Times and an associate professor of dermatology at Yale School of Medicine in New Haven, Connecticut, gave an exclusive statement to Dermatology Times. "AD patients receiving biologic therapies desire less frequent dosing regimens, especially when their skin is clear and itch controlled. FDA approval of lebrikizumab for use every 8 weeks as a maintenance regimen is welcome news, giving dermatologists and patients more flexibility in how they manage AD. Every 8 weeks maintenance dosing for lebrikizumab is a significant differentiator among IL-13 and IL-4R targeted biologics and must be considered in shared clinical decision making."

References

1. FDA approves Lilly's EBGLYSS® (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis. News release. Eli Lilly and Company. 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. Lebrikizumab delivered long-term disease control for up to four years in patients with moderate-to-severe atopic dermatitis. News release. Almirall. Published March 27, 2026. Accessed June 10, 2026. https://www.almirall.com/newsroom/news/lebrikizumab-delivered-long-term-disease-control-for-up-to-four-years-in-patients-with-moderate-to-severe-atopic-dermatitis