Ebglyss (Lebrikizumab) Approval Adds 8-Week Maintenance Option for Eczema

The new FDA approval allows eligible patients who respond to Ebglyss to receive maintenance treatment every eight weeks instead of every four weeks. 

The FDA has approved an expanded dosing regimen for Eli Lilly’s Ebglyss (lebrikizumab-lbkz), a biologic treatment for moderate-to-severe atopic dermatitis.

The approval allows eligible patients to receive a 250 mg maintenance dose once every eight weeks. Ebglyss was already approved as a once-monthly maintenance treatment, meaning the new regimen gives some patients a less frequent option after they have achieved an initial clinical response.

The updated regimen applies to adults and adolescents 12 years of age and older who weigh at least 88 pounds and have moderate-to-severe atopic dermatitis that is not well controlled with prescription topical therapies, or who cannot use those treatments.

Atopic dermatitis, often called eczema, is a chronic inflammatory skin disease that can cause persistent itching, skin inflammation and flares. In moderate-to-severe cases, topical treatments may not be enough, leading some patients to need systemic options such as biologics.

Xtalks Insights

Get industry leading pharma and biotech news, events and expert insights delivered to your inbox.

First Name *

Email *

By clicking this checkbox, I agree to receive Xtalks communications and understand that I may unsubscribe at any time. Please review the Xtalks privacy policy here.

Protected by reCAPTCHA.

Continue

What topics would you like to hear more about?

Select all that apply.

Science and Discovery Clinical Development Regulatory Safety and Quality Manufacturing and Supply Chain Commercial and Market Access Data AI and Digital Therapeutic Areas

Progress

1 2 3

Next Step

Want to get even more specific?

Help us narrow down the sub-topics that you're most interested in.

Progress

1 2 3

Save Preferences

Thank you!

For webinars, videos, podcasts and more from Xtalks, join our community today.

BECOME A FREE MEMBER

Progress

1 2 3

New Ebglyss Schedule Could Reduce Maintenance Injections

The treatment schedule for Ebglyss includes an initial loading phase followed by long-term maintenance dosing. Patients receive 500 mg at Week 0 and Week 2, followed by a 250 mg injection every two weeks until Week 16 or later, once an adequate clinical response is reached.

After that, healthcare providers can move eligible patients to maintenance dosing every four weeks or every eight weeks. The extended schedule could reduce the number of maintenance injections to as few as six per year.

How Ebglyss Targets Skin Inflammation 

Ebglyss is a monoclonal antibody that targets interleukin-13, or IL-13, an immune protein involved in type 2 inflammation. In atopic dermatitis, this inflammatory pathway contributes to itching, skin inflammation and damage to the skin barrier.

By blocking IL-13 signaling, Ebglyss is intended to help reduce the inflammatory cycle that drives moderate-to-severe atopic dermatitis.

Related: Understanding Itch, Sensitive Skin and Systemic Disease Through a Global Dermatology Lens

ADjoin Data Support Eight-Week Maintenance Dosing 

The ADjoin extension evaluated lebrikizumab-lbkz over 32 weeks in adults and adolescents who had participated in earlier Phase III studies. Researchers measured response using the Investigator’s Global Assessment, or IGA, and the Eczema Area and Severity Index, or EASI.

The IGA measures skin clarity, with a score of 0 or 1 indicating clear or almost clear skin. At Week 32, 62% of patients on the every-eight-week maintenance schedule had an IGA score of 0 or 1, compared with 73% of those on the every-four-week schedule.

EASI measures the extent and severity of eczema. EASI 75 means at least a 75% improvement in the EASI score, while EASI 90 reflects at least a 90% improvement.

At Week 32, 79.1% of patients on the every-eight-week schedule achieved EASI 75, compared with 86.2% on the every-four-week schedule. For EASI 90, the corresponding rates were 68.7% and 78.2%, respectively.

The study was not designed to prove that the two maintenance schedules were equivalent. However, the data supported the eight-week interval as an option for some patients who had already responded to treatment.

Lilly said no new safety signals were identified in the 32-week ADjoin extension, and no patients discontinued treatment because of adverse events.

The Phase III program for Ebglyss includes seven global studies involving more than 1,600 patients. The program includes studies of lebrikizumab-lbkz alone, in combination with topical corticosteroids and in long-term follow-up. It also includes studies in adolescents, patients with skin of color and patients previously treated with dupilumab.

Ebglyss was approved in the European Union in 2023 and in the US, Japan and Canada in 2024. Lilly holds rights to the drug in the US and outside Europe, while Almirall holds European rights for dermatology indications.

The latest FDA approval gives some patients who respond to Ebglyss a less frequent long-term dosing option, with injections given every eight weeks instead of every four weeks.

Other companies are also testing atopic dermatitis treatments that may offer longer-lasting symptom control with less frequent dosing. In May 2026, Apogee Therapeutics reported Phase II data for zumilokibart, an investigational anti-IL-13 antibody, and secured up to $1.3 billion from Blackstone Life Sciences to support later-stage development. Sanofi has also reported Phase III data for amlitelimab, an investigational biologic being studied with every-four-week and every-12-week dosing.