The U.S. Food and Drug Administration (FDA) approved a new maintenance dosing schedule for Eli Lilly's EBGLYSS (lebrikizumab-lbkz). This approval targets patients with moderate-to-severe atopic dermatitis. The new schedule permits a 250 mg injection once every eight weeks. This applies to adults and adolescents aged 12 years and older, following an initial induction period. This offers greater convenience than the previous once-monthly regimen. It reduces maintenance injections to as few as six per year.
The new dosing option is for patients who achieve an adequate clinical response after starting treatment. This less frequent regimen could provide EBGLYSS a competitive edge against other treatments requiring more frequent injections. Data from the Phase 3 ADjoin long-term extension trial supported the approval. The trial demonstrated the efficacy and safety of the eight-week schedule. The trial identified no new safety concerns.