FDA approves 8-week EBGLYSS dosing for atopic dermatitis patients

The FDA has approved a new every-eight-week dosing option for EBGLYSS. This treatment is for adults and children aged 12 and older with moderate-to-severe atopic dermatitis. Patients may now need as few as six maintenance injections per year. The approval follows longitudinal exposure-response modelling and data from the ADjoin long-term trial. In the 32-week ADjoin Q8W extension, no new safety issues were reported with the every-eight-week dosing. Common side effects include conjunctivitis, injection site reactions, and herpes zoster.

With the new regimen, EBGLYSS does not require prescription topicals from the beginning. Lilly holds exclusive rights for its development and commercialisation worldwide, except in Europe. Almirall has licensed the rights for dermatology uses, including atopic dermatitis, in Europe. The new dosing option reduces the number of injections patients need annually. It offers a more convenient treatment schedule for those managing moderate-to-severe atopic dermatitis. The approval applies to adults and adolescents aged 12 and above.