Eli Lilly and Company announced that the FDA has approved a new EBGLYSS (lebrikizumab-lbkz) maintenance regimen of a single 250 mg/2 mL subcutaneous injection every eight weeks for adults and adolescents 12 years and older with moderate-to-severe atopic dermatitis who weigh at least 88 pounds (40 kg). EBGLYSS was already approved for once-monthly maintenance dosing with long-term data demonstrating durable disease control, and the new label now allows eligible patients to manage their disease with as few as six maintenance injections per year. According to Lilly, the option to extend dosing to every eight weeks offers an additional choice for patients seeking durable control without the need for prescription topical therapies from treatment initiation.
The FDA decision is based on longitudinal exposure–response modeling and supported by every-eight-week clinical data from an extension of the Phase 3 ADjoin long-term trial, which evaluated EBGLYSS maintenance dosing every four weeks or every eight weeks over 32 weeks. Investigators reported that the extended-interval regimen provides a flexible approach to tailoring treatment based on individual patient needs, without mandatory concomitant topical therapy. No new safety signals were observed in the 32-week ADjoin every-eight-week extension, and no patients discontinued due to adverse events over that period. The most common adverse reactions occurring in at least 1% of patients treated with EBGLYSS were conjunctivitis, injection site reactions and herpes zoster.
Patient advocates highlighted that people living with moderate-to-severe atopic dermatitis often face a burdensome cycle of symptoms and time-intensive treatment routines between flares, and emphasized that options offering durable disease control with fewer injections can help reduce that daily burden. Lilly holds exclusive rights to develop and commercialize EBGLYSS in the United States and in markets outside Europe, while Almirall has licensed rights to develop and commercialize EBGLYSS for dermatology indications, including atopic dermatitis, in Europe.
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