Lilly gains FDA approval for EBGLYSS every‑eight‑week maintenance dosing

Regulatory change

The FDA approved a maintenance regimen of one 250 mg/2 mL subcutaneous injection every eight weeks of EBGLYSS (lebrikizumab‑lbkz) for adults and children 12 years of age and older who weigh at least 40 kg with moderate‑to‑severe atopic dermatitis. EBGLYSS was already approved for once‑monthly maintenance; the Q8W option allows patients to receive as few as six maintenance injections per year and can be initiated without mandatory prescription topical therapy.

Clinical evidence

The approval was based on longitudinal exposure‑response modelling and supported by data from an eight‑week (Q8W) extension of the Phase 3 ADjoin long‑term trial, which assessed Q4W and Q8W maintenance dosing over 32 weeks. Participants in the extension had completed the ADjoin long‑term study and prior Phase 3 trials and received open‑label EBGLYSS 250 mg Q8W or Q4W regardless of previous dose or response.

Safety profile

No new safety signals were observed in the ADjoin Q8W extension and no patients discontinued due to adverse events through 32 weeks. The most common adverse reactions (≥1%) were conjunctivitis, injection‑site reactions and herpes zoster. Warnings noted in the label include allergic reactions and potential eye problems, and live vaccines should not be given during treatment.

Dosing and commercial notes

Recommended initiation is 500 mg (two 250 mg injections) at Week 0 and Week 2, then 250 mg every two weeks until Week 16 or until adequate clinical response, after which maintenance is 250 mg every four weeks or every eight weeks. Lilly holds development and commercialization rights outside Europe; Almirall holds rights in Europe. EBGLYSS was previously approved in the U.S., Japan and Canada in 2024 and in the European Union in 2023.