Lebrikizumab is currently the only approved treatment option requiring as few as six maintenance injections per year, and does not require concomitant use of topical medications during the initial treatment phase.
ShanghaiJune 15, 2026 /PRNewswire/ — Eli Lilly and Company announced that the U.S. Food and Drug Administration (FDA) has approved a new maintenance dosing regimen for lebrikizumab, allowing administration every eight weeks as a single subcutaneous injection (250 mg/2 mL) for adult and adolescent patients aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis. Lebrikizumab was previously approved for a monthly maintenance dosing regimen, with long-term data demonstrating durable disease control. This new approval of the lebrikizumab regimen provides patients with moderate-to-severe atopic dermatitis a treatment option requiring as few as six maintenance injections per year1.
Disclaimer:
1. The drug and related indications described in this article have not been approved in mainland China.
2. Eli Lilly does not recommend the use of any unapproved drugs and/or unapproved indications.
Adrienne Brown, Executive Vice President and President of Immunology at Eli Lilly, stated: “This approval further reinforces the proven long-term durable efficacy of lebrikizumab, while also offering patients a new option for maintenance treatment every eight weeks. For patients with moderate-to-severe atopic dermatitis, this means they require as few as six injections per year and do not need concomitant use of topical prescription medications from the start of treatment. Lebrikizumab has the potential to help patients reduce disease flares and lessen the impact of atopic dermatitis on daily life.”
This approval is based on longitudinal exposure-response model data and is supported by clinical data from the every-eight-week dosing regimen in the Phase 3 ADjoin long-term extension study. This extension study evaluated lebrikizumab maintenance dosing regimens administered every four weeks or every eight weeks over 32 weeks2.
Dr. Peter Lio, Clinical Assistant Professor of Dermatology and Pediatrics at Northwestern University and author of the ADjoin study, noted: “Extending the maintenance dosing interval of lebrikizumab to every eight weeks is significant for patients with moderate-to-severe atopic dermatitis. This new regimen, which does not rely on concomitant topical therapy, allows patients to manage their disease more flexibly based on their individual circumstances, truly aligning treatment with patients’ real lives.”
In the 32-week ADjoin Q8W extension study, no new safety signals were observed in the lebrikizumab safety data. No patients discontinued treatment due to adverse events over the 32 weeks. The most common (≥1%) adverse reactions reported for lebrikizumab included conjunctivitis, injection site reactions, and herpes zoster1.
Kristin Belleson, President and CEO of the National Eczema Association, stated: “Patients with moderate-to-severe atopic dermatitis often have to manage recurrent flares, cycling between flare-ups and remission periods, requiring significant time spent on treatment. Therefore, there is an urgent need for treatment options that provide durable disease control with fewer injections. This new treatment option can alleviate their burden, allowing them to spend less energy managing their disease every day.”
Eli Lilly China has submitted a marketing application for lebrikizumab, which is currently under review by the Center for Drug Evaluation of the National Medical Products Administration.
CMAT-35789
About the Q8W ADjoin Extension Study
The ADjoin Q8W extension study (NCT04392154) evaluated lebrikizumab administered every eight weeks (Q8W) versus every four weeks (Q4W), assessing the long-term safety and efficacy of lebrikizumab over 32 weeks in patients with moderate-to-severe atopic dermatitis in selected countries. Adult and adolescent patients (12-17 years, weight ≥40 kg) who completed the 100-week ADjoin study, including participants from the ADvocate 1 and 2 trials (52 weeks), the ADore trial (52 weeks), and the ADopt-VA trial (16 weeks), were eligible to participate in the Q8W extension study. Patients in this analysis received open-label lebrikizumab 250 mg Q8W or Q4W, regardless of their prior treatment in ADjoin (Q2W or Q4W dosing) or their response status at the extension study baseline. The approved maintenance dose of lebrikizumab is 250 mg every four weeks or every eight weeks, following 16 weeks of lebrikizumab 250 mg every two weeks, or after achieving an adequate clinical response.
About Lebrikizumab
Lebrikizumab is a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and slow dissociation rate.1,3,4 Lebrikizumab binds to the IL-13 cytokine at a site overlapping with the binding site of the IL-4Rα subunit in the IL-13Rα1/IL-4Rα heterodimer, thereby preventing the formation of this receptor complex and inhibiting IL-13 signaling. IL-13 is considered a key cytokine closely associated with the pathophysiology of atopic dermatitis, driving the type 2 inflammatory cycle in the skin, and lebrikizumab selectively targets IL-13.1
The global Phase 3 clinical development program for lebrikizumab consists of seven pivotal studies, enrolling over 1,600 patients, including two monotherapy studies (ADvocate 1 and 2), one combination therapy study with topical corticosteroids (ADhere), a long-term extension study (ADjoin), and an adolescent open-label study (ADore). The program also includes a study evaluating the impact of lebrikizumab on vaccine immune responses in adults (ADopt-VA). Lebrikizumab has been studied in patients with skin of color (ADmirable) and in patients previously treated with dupilumab (ADapt).
Lebrikizumab was approved in the United States, Japan, and Canada in 2024, and in the European Union in 2023. As a first-line biologic treatment option, it can be used as monotherapy or in combination with topical corticosteroids, providing a maintenance dosing regimen every four weeks (Q4W) or every eight weeks (Q8W) for patients aged 12 years and older weighing at least 40 kg with moderate-to-severe atopic dermatitis inadequately controlled with prescription topical therapies1. In the United States, the recommended starting dose of lebrikizumab is 500 mg (two 250 mg injections) at Week 0 and Week 2, followed by 250 mg every two weeks until Week 16 or until adequate clinical response is achieved; thereafter, the maintenance dose is 250 mg every four weeks or 250 mg every eight weeks1.
Eli Lilly holds exclusive rights to develop and commercialize lebrikizumab in the United States and globally outside of Europe; Lilly’s partner Almirall holds the rights to develop and commercialize lebrikizumab for dermatological indications, including atopic dermatitis, in Europe.
About Eli Lilly
Eli Lilly and Company is a pharmaceutical company dedicated to improving human health through scientific innovation, benefiting patients worldwide. As a leader in the healthcare industry, Eli Lilly has a 150-year history. Today, our medicines help millions of people globally. Leveraging the power of biotechnology, chemistry, and genetic medicine, our scientists are actively advancing new medical breakthroughs to address serious global health challenges. Redefining diabetes and obesity therapy, reducing the long-term impact of obesity on the body; aiding in the prevention and treatment of Alzheimer’s disease; providing solutions for a range of immune-mediated diseases threatening human health; and transforming difficult-to-treat cancers into manageable diseases. Every step Eli Lilly takes toward a healthier world stems from our belief in “making life better for millions of patients.” This includes innovative clinical trials addressing multiple global challenges while ensuring drug accessibility and affordability. For more information about Eli Lilly, please visit: www.lilly.com.cn
References:
- EBGLYSS prescribing information. Lilly USA, LLC.
- Jonathan Silverberg, et al. Lebrikizumab every 8 weeks as maintenance dose provides long-lasting response in patients with moderate-to-severe atopic dermatitis. Presented at: Fall Clinical Dermatology Conference; 2025.