FDA Approves Ebglyss for Treatment of Moderate to Severe Atopic Dermatitis

Ebglyss injector © Lilly

The FDA has approved Lilly’s Ebglyss (lebrikizumab-lbkz) for the treatment of moderate to severe atopic dermatitis in adults and children ages 12 and older, according to a recently published news release.

This approval is based on the results of the ADvocate 1, ADvocate 2, and ADhere studies that included more than 1,000 patients who struggled to keep their symptoms under control with topical prescription medicines.

In the average of the ADvocate 1 and ADvocate 2 studies, 38% of people who took Ebglyss achieved clear or almost clear skin within 16 weeks and 77% of these patients maintained clarity for one year with monthly dosing. Only 48% of patients kept clear skin after they were switched to placebo after week 16.

The recommended starting dose of Ebglyss is 500 mg, administered as two 250 mg injections given right away and again two weeks later. This is followed by a single 250 mg injection every two weeks until week 16 or later when adequate clinical response is achieved. Ebglyss is then given monthly as a maintenance dose. It can be used with or without topical corticosteroids.

“Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies,” Jonathan Silverberg, M.D., Ph.D., M.P.H., professor of dermatology at George Washington University School of Medicine and Health Sciences in Washington, D.C., and first author of the New England Journal of Medicine manuscript summarizing Ebglyss clinical trials said in the news release. “Many experience poor long-term disease control, and severe itch can significantly impact their daily lives. Today's FDA approval of Ebglyss is a big win for patients, as we now have a new first-line biologic treatment option for moderate-to-severe disease when topical prescriptions aren't enough."

Conjunctivitis, including allergic conjunctivitis, was the most reported side effect during the initial 16 weeks of treatment during the ADvocate 1 and ADvocate 2 studies. It affected 61 subjects (10%) in the comparison group and 3% (10) in the placebo group.

Patients with moderate to severe atopic dermatitis may experience intense itching or burning that can lead to oozing and crusted, thickened skin from scratching. Flare ups cans be caused by factors including stress, allergies and weather changes and can last anywhere from days to weeks.

Lilly plans to offer a patient support program to help with co-pay assistance for eligible, commercially insured patients. Covered patients could pay as little as $5 a month, according to a Lilly media representative.

Ebglyss will be available in the United States in the coming weeks.