June 9, 2026 — Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved a new dosing regimen for EBGLYSS (lebrikizumab-lbkz). The regimen is a single subcutaneous injection (250 mg/2 mL) once every 8 weeks, indicated for adults and pediatric patients aged 12 years and older, weighing at least 88 pounds (40 kg), with moderate-to-severe atopic dermatitis (eczema).
Previously, EBGLYSS had been approved for a monthly (once every 4 weeks) maintenance dosing regimen, with long-term data showing durable disease control. Now, the newly approved regimen offers a new option for patients with moderate-to-severe atopic dermatitis, allowing them to manage their condition with as few as 6 maintenance injections per year.
Basis of Approval
This approval is based on longitudinal exposure-response model data and is supported by clinical data on every-8-week dosing from the long-term extension of the ADjoin trial. The extension study evaluated EBGLYSS maintenance dosing regimens of every 4 weeks or every 8 weeks over 32 weeks.
Safety
In the safety data for EBGLYSS from the 32-week ADjoin Q8W extension study, no new safety signals were identified. No patients discontinued treatment due to adverse events throughout the 32 weeks. Common adverse reactions (≥1%) reported with EBGLYSS include conjunctivitis, injection site reactions, and herpes zoster.
Indication and Safety Summary
EBGLYSS is indicated for the treatment of moderate-to-severe atopic dermatitis in patients aged 12 years and older, weighing at least 40 kg, whose disease is not adequately controlled with prescription topical therapies or when those therapies are not advisable.
Warning
Do not use if you are allergic to lebrikizumab-lbkz or any ingredient in EBGLYSS.
Tell your doctor before using
If you have a parasitic infection, if you plan to receive any vaccines (live vaccines should not be given during treatment), if you are pregnant or plan to become pregnant, if you are breastfeeding or plan to breastfeed.
Possible serious side effects
Include allergic reactions (e.g., trouble breathing, swelling of the face, hives) and eye problems (e.g., eye pain or vision changes). The most common side effects include: inflammation of the eyelids (redness, itching), injection site reactions, and herpes zoster.
Comments from Eli Lilly Executives and Experts
"Today's approval builds on the established long-term durable efficacy of EBGLYSS, offering a new choice of an every-8-week maintenance dose. For patients with moderate-to-severe atopic dermatitis, this means they can be treated without the need for prescription topical therapies from the start, requiring as few as 6 treatments per year," said Adrienne Brown, Executive Vice President and President of Lilly Immunology. "EBGLYSS now gives patients the opportunity to reduce flares and have fewer interruptions to their daily lives due to atopic dermatitis."
"The option to extend EBGLYSS maintenance dosing to once every 8 weeks is a significant moment for patients with moderate-to-severe atopic dermatitis," said Dr. Peter Lio, Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University and author of the ADjoin study. "This new dosing regimen, which does not require mandatory use of topical therapies, provides patients with a new option to manage their condition according to their individual needs, truly addressing where patients are in their lives."
