FDA Approves Extended Dosing Schedule for EBGLYSS

Eli Lilly and Company has received approval from the U.S. Food and Drug Administration (FDA) for an expanded dosing schedule of EBGLYSS® (lebrikizumab-lbkz), allowing eligible patients with moderate-to-severe atopic dermatitis to receive maintenance treatment as infrequently as once every eight weeks.

The approval applies to adults and adolescents aged 12 years and older who weigh at least 88 pounds (40 kilograms) and have moderate-to-severe atopic dermatitis, commonly known as eczema. With the new regimen, patients can maintain disease control with as few as six injections per year following the initial treatment phase, offering a more convenient alternative to more frequent maintenance schedules.

EBGLYSS was previously approved with a once-monthly maintenance dosing schedule. The latest FDA decision expands treatment flexibility and provides patients and healthcare providers with an additional option based on individual disease management needs.

According to Lilly, the approval was supported by longitudinal exposure-response modeling data as well as clinical findings from an extension of the Phase III ADjoin long-term study. The extension evaluated maintenance dosing every four weeks and every eight weeks over a 32-week period, demonstrating that disease control could be maintained with the less frequent dosing schedule.

Atopic dermatitis is a chronic inflammatory skin condition characterized by intense itching, skin inflammation, dryness, and recurring flare-ups. Moderate-to-severe forms of the disease can significantly impact sleep, mental health, productivity, and overall quality of life. Many patients require long-term treatment to control symptoms and prevent relapses.

Adrienne Brown, Executive Vice President and President of Lilly Immunology, said the approval builds on the long-term durability already demonstrated by EBGLYSS. She noted that the ability to administer maintenance treatment every eight weeks allows patients to manage their condition with fewer interruptions while reducing treatment burden.

“Patients now have the option of receiving treatment as few as six times a year without requiring prescription topical therapies from the start,” Brown said.

Clinical experts welcomed the approval as a meaningful advancement for eczema care. Dr. Peter Lio, clinical assistant professor of dermatology and pediatrics at Northwestern University and an author of the ADjoin study, said the extended dosing schedule represents an important step toward individualized treatment. He emphasized that the new option gives physicians greater flexibility to tailor therapy to patients’ lifestyles and long-term disease management goals.

The safety profile observed during the ADjoin extension remained consistent with previous studies of EBGLYSS. Lilly reported that no new safety signals emerged during the 32-week extension period and no patients discontinued treatment due to adverse events. The most commonly reported side effects included conjunctivitis, injection-site reactions, and herpes zoster.

Patient advocacy groups also highlighted the potential benefits of the new regimen. Kristin Belleson, President and Chief Executive Officer of the National Eczema Association, noted that living with moderate-to-severe atopic dermatitis often involves managing persistent symptoms and time-consuming treatment routines. She said fewer injections could help reduce the daily burden of disease management and improve quality of life for many patients.

EBGLYSS is a targeted biologic therapy designed to inhibit interleukin-13 (IL-13), a key driver of inflammation associated with atopic dermatitis. The treatment has demonstrated durable disease control in clinical trials and continues to expand its role in the management of chronic inflammatory skin diseases.

Lilly holds exclusive rights to develop and commercialize EBGLYSS in the United States and most global markets outside Europe. In Europe, dermatology rights for the therapy are held by Almirall.

The FDA approval marks another milestone in the evolving treatment landscape for atopic dermatitis, offering patients a new option that combines sustained efficacy with a reduced treatment schedule.