FDA Approves EBGLYSS 8-Week Dosings in Atopic Dermatitis

Key Takeaways

• The U.S. Food and Drug Adminstration (FDA) has approved an every-eight-week maintenance dosing regimen for EBGLYSS (lebrikizumab-lbkz) in eligible patients with moderate-to-severe atopic dermatitis.
• EBGLYSS is now the only approved atopic dermatitis treatment offering as few as six maintenance injections annually without requiring prescription topical therapies from treatment initiation.
• The approval was supported by data from the Phase 3 ADjoin extension study and longitudinal exposure-response modeling, with no new safety signals identified.

The US Food and Drug Administration (FDA) has approved an every-8-week maintenance dosing regimen for EBGLYSS® (lebrikizumab-lbkz) in adults and adolescents aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis, according to an announcement from manufacturer Eli Lilly.

The interleukin (IL)-13 inhibitor was previously approved for once-monthly maintenance administration. According to a press release from Lilly, EBGLYSS is now the only approved treatment for moderate-to-severe atopic dermatitis that offers as few as six maintenance injections annually without requiring prescription topical therapies from treatment initiation.

The FDA decision was based on longitudinal exposure-response modeling and supported by clinical data from the Phase 3 ADjoin extension study. The trial evaluated maintenance dosing every four weeks and every eight weeks over a 32-week period and demonstrated sustained disease control with less frequent administration.

Peter Lio, MD, clinical assistant professor of dermatology and pediatrics at Northwestern University and an investigator in the ADjoin study, said the approval provides additional flexibility for patients managing a chronic inflammatory skin disease.

“The option to extend EBGLYSS maintenance dosing to every eight weeks represents an important moment for patients living with moderate-to-severe atopic dermatitis,” Lio said. “This new dosing regimen without mandatory topicals gives patients a new option to manage their condition based on individual needs.”

No new safety signals were reported. Lilly reported that no patients discontinued treatment because of adverse events during the study period. The most commonly reported adverse reactions associated with EBGLYSS include conjunctivitis, injection-site reactions, and herpes zoster.

Source

Eli Lilly news release. June 9, 2026.