FDA approves less frequent Ebglyss dosing for atopic dermatitis

FDA has approved an every-eight-week maintenance dosing option for Ebglyss (lebrikizumab-lbkz) in adults and children aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis. The new regimen adds a less frequent maintenance option to the existing monthly dosing schedule.

Atopic dermatitis often requires long-term treatment, and treatment burden can affect adherence and quality of life. The newly approved regimen gives patients and clinicians greater flexibility in maintaining disease control while reducing the frequency of injections with this subcutaneous biologic.

Ebglyss is now the only approved therapy for moderate-to-severe atopic dermatitis that offers maintenance dosing as infrequently as six injections per year without requiring topical therapies from the start of treatment.

The FDA decision was supported by long-term data from the phase 3 ADjoin study and exposure-response modeling analyses. Clinical data demonstrated that disease control was maintained with every-eight-week dosing in patients who'd achieved an adequate response to therapy.

No new safety signals were identified with the less frequent dosing regimen. The most common adverse reactions reported with Ebglyss include conjunctivitis, injection-site reactions, and herpes zoster.

“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, clinical assistant professor of dermatology and pediatrics at 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.”

Source: Lilly. 2026 June 9. [Press release]. FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis