FDA Approves Every-8-Week Maintenance Dosing Option for Lebrikizumab in Atopic Dermatitis
The FDA approved an every-8-week maintenance dosing regimen for Ebglyss (lebrikizumab-lbkz), providing a new administration option for adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis (AD).
Ebglyss was previously approved with once-monthly maintenance dosing. With the updated label, eligible patients may receive a single 250-mg injection every 8 weeks after initial treatment and achievement of adequate clinical response, reducing maintenance treatment to as few as 6 injections per year.
Lebrikizumab is a monoclonal antibody that selectively targets IL-13, a cytokine implicated in the type 2 inflammatory pathway that drives AD. By binding IL-13 and preventing formation of the IL-13Rα1/IL-4Rα receptor complex, the therapy inhibits IL-13 signaling.
The approval was supported by longitudinal exposure-response modeling and clinical data from the phase 3 ADjoin extension study, which evaluated maintenance dosing every 4 weeks and every 8 weeks over 32 weeks in patients with moderate-to-severe AD. Adult and adolescent patients who completed the long-term ADjoin study were eligible to participate.
According to Lilly, no new safety signals were identified during the 32-week every-8-week extension period, and no patients discontinued treatment because of adverse events. The most common adverse reactions reported with Ebglyss include conjunctivitis, injection-site reactions, and herpes zoster.
Ebglyss is approved for use with or without topical corticosteroids in patients whose disease is not adequately controlled with topical prescription therapies or who cannot use topical therapies. The recommended starting regimen remains 500 mg at weeks 0 and 2, followed by 250 mg every 2 weeks until week 16 or later when adequate clinical response is achieved, after which patients may transition to maintenance dosing every 4 weeks or every 8 weeks.
Reference
FDA approves Lilly's EBGLYSS (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis. News release. June 9, 2026. Accessed June 10, 2026. https://investor.lilly.com/news-releases/news-release-details/fda-approves-lillys-ebglyssr-lebrikizumab-lbkz-one-maintenance
