FDA Approves Lebrikizumab for 8 Week Maintenance of Atopic Dermatitis

The FDA approved a new maintenance dosing regimen for Eli Lilly and Company’s lebrikizumab-lbkz (Ebglyss), allowing for a single 250 mg injection every 8 weeks in patients with moderate-to-severe atopic dermatitis. This approval establishes lebrikizumab as the only biologic option for this indication that offers as few as 6 maintenance injections per year without the requirement of topical corticosteroids from the start of treatment.¹

The expanded label applies to adults and pediatric patients 12 years and older who weigh at least 40 kg and whose disease is not adequately controlled with topical prescription therapies.

"Today's approval builds on Ebglyss’ established long-term durability, with a new option for 1 maintenance dose every 8 weeks. For people living with moderate-to-severe atopic dermatitis, that means a treatment they only need to take as few as 6 times a year—without prescription topicals from the start," Adrienne Brown, executive vice president and president of Lilly Immunology, said in a news release.¹ "Ebglyss now gives patients the opportunity to flare less and live their lives with fewer interruptions from atopic dermatitis."

For pharmacists managing patient transitions from induction to maintenance therapy, the dosing protocol remains specific to individual clinical response. The recommended initial starting dose is 500 mg, delivered via 2 250 mg injections at week 0 and week 2, followed by 250 mg every 2 weeks until week 16 or until an adequate clinical response is achieved. Once stable, patients may now transition to a maintenance phase of 250 mg every 4 weeks or the newly approved every-8-week schedule. This flexibility is intended to meet patients where they are in their lives and reduce the overall treatment burden.^1-3

Data Supporting the Approval

The FDA’s decision was informed by longitudinal exposure-response modeling data and supported by clinical results from the phase 3 ADjoin (NCT04392154) long-term extension trial. In this trial, maintenance dosing every 8 weeks demonstrated high rates of disease control comparable to the previously approved monthly dosing.^1,2

Specifically, 79% of patients on the 8-week schedule achieved or maintained a 75% reduction in their Eczema Area and Severity Index (EASI 75) score, compared with 86% of those on monthly dosing. Furthermore, 62% of patients on the eight-week regimen achieved or maintained an Investigator’s Global Assessment (IGA) score of 0 or 1, signifying clear or almost clear skin.²

Lebrikizumab functions as a monoclonal antibody that selectively targets and neutralizes IL-13 with high binding affinity and a slow dissociation rate. By preventing the formation of the IL-13Rα1/IL-4Rα receptor complex, the drug inhibits the signaling of IL-13, a primary cytokine driving the type-2 inflammatory loop that leads to skin barrier dysfunction, itch, and skin thickening in atopic dermatitis. Long-term data underscored the durability of this mechanism, with approximately 87% of week 16 responders maintaining EASI 75 clearance at 3 years.^2,4

The Pharmacist’s Role

Pharmacists should be prepared to counsel patients on the safety profile and proper administration of lebrikizumab, which is available in 250 mg/2 mL prefilled pens and syringes. The most common adverse reactions reported in clinical trials include conjunctivitis, injection site reactions, and herpes zoster.^1,3

Patients should be monitored for new or worsening eye symptoms, such as redness or blurred vision, and must be advised to stop the medication and seek emergency care if signs of a severe allergic reaction, such as angioedema or urticaria, occur.^1-3

Handling and storage requirements are also critical for retail and specialty pharmacy teams to communicate. Lebrikizumab must be stored in the refrigerator, but a prefilled pen or syringe may be kept at room temperature for up to 7 days if necessary. It should be discarded if not used within that window. Patients should be instructed to rotate injection sites—using the thigh, stomach, or upper arm—and to never inject into skin that is tender, bruised, or affected by eczema.³

Prior to initiating therapy, pharmacists should verify that patients are not scheduled for any live vaccinations, as these are contraindicated during lebrikizumab treatment. Additionally, patients with pre-existing parasitic infections should be treated for those conditions before starting the biologic. To support treatment access, Lilly offers patient support services and co-pay assistance for eligible commercially insured patients, with broad coverage already established across major national pharmacy benefit managers.^1-3

"The option to extend Ebglyss maintenance dosing to every 8 weeks represents an important moment for patients living with moderate-to-severe atopic dermatitis," Peter Lio, MD, author of the ADjoin study and clinical assistant professor of dermatology and pediatrics at Northwestern University, said in the news release.¹ "This new dosing regimen without mandatory topicals gives patients a new option to manage their condition based on individual needs. It's about meeting patients where they are in their lives."

READ MORE: Dermatology Resource Center

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REFERENCES

1. FDA approves Lilly's Ebglyss (lebrikizumab-lbkz) for one maintenance dose every eight weeks in patients with moderate-to-severe atopic dermatitis. News release. Eli Lilly. June 9, 2026. Accessed June 10, 2026. https://lilly.gcs-web.com/news-releases/news-release-details/fda-approves-lillys-ebglyssr-lebrikizumab-lbkz-one-maintenance

2. Lilly's Ebglyss (lebrikizumab-lbkz) delivered durable disease control when administered once every eight weeks in patients with moderate-to-severe atopic dermatitis. News release. Eli Lilly. October 24, 2025. Accessed June 10, 2026. https://lilly.gcs-web.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-delivered-durable-disease

3. Mayo Clinic. Lebrikizumab-lbkz (subcutaneous route). February 1, 2026. Accessed June 10, 2026. https://www.mayoclinic.org/drugs-supplements/lebrikizumab-lbkz-subcutaneous-route/description/drg-20573774

4. Gallagher A. Lebrikizumab demonstrates sustained response for atopic dermatitis at 3 years. Drug Topics. March 8, 2025. Accessed June 10, 2026. https://www.drugtopics.com/view/lebrikizumab-demonstrates-sustained-response-for-atopic-dermatitis-at-3-years