FDA approves new Ebglyss maintenance dose for moderate to severe atopic dermatitis patients

The FDA has approved a new maintenance dose regimen of Ebglyss (lebrikizumab-lbkz) for patients with moderate to severe atopic dermatitis ages 12 and older weighing at least 88 lbs, according to an Eli Lilly and Company news release.

The approved dose is one injection (250 mg/2 mL) given subcutaneously every eight weeks, making Ebglyss the only FDA-approved option offering as few as six maintenance injections per year, with no required topicals, the release states.

This approval was made using clinical data from an extension to the phase 3 ADjoin long-term trial, which evaluated the effectiveness of the maintenance dose given every eight weeks compared with every four weeks.

"The option to extend EBGLYSS maintenance dosing to every eight weeks represents an important moment for patients living with moderate-to-severe atopic dermatitis," Peter Lio, M.D., author of the ADjoin study and clinical assistant professor of dermatology and pediatrics, Northwestern University, said in the news release. "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."

There were no new safety concerns identified in the 32-week ADjoin Q8W extension and no patients discontinued use during treatment. The most common side effects during the trial, occurring in at least 1% of patients, were conjunctivitis, injection site reactions and herpes zoster.

Ebglyss was originally approved in the United States in 2024. The recommended starting dose is 500 mg given as two 250 mg injections at week 0 and week 2. This is followed by 250 mg every two weeks until week 16 or later, when an adequate clinical response is achieved.

Eczema is a collection of skin conditions that cause dry, itchy and inflamed skin, which affects approximately 31.6 million people in the United States.

Atopic dermatitis is the most common type of eczema, affecting approximately 16.5 million adults and 9.6 million children in the United States. Of those individuals, 6.6 million have moderate to severe atopic dermatitis.

Moderate atopic dermatitis affects large areas of skin that can become scaly, cracked and thick. It typically requires prescription treatment and can interfere with sleep or daily tasks.

For patients with severe atopic dermatitis, patients experience widespread swelling and itching, which can lead to bleeding and secondary infections. Symptoms may be present most days of the week.

Ebglyss is a monoclonal antibody that works by targeting and neutralizing IL-13, the key mediator in allergic inflammation. In patients with moderate to severe atopic dermatitis, IL-13 causes the skin barrier to break down and stimulates sensory nerves in the skin that cause the itch. By binding to IL-13 and blocking it from activating its receptor, the drug interrupts the inflammatory process at its source. Its strong and lasting hold on IL-13 is thought to be a key reason patients were able to maintain disease control even after switching to the less frequent dosing schedule.

"Living with moderate-to-severe atopic dermatitis often means dealing with a cycle of symptoms and time-intensive treatment routines during and in-between flares," Kristin Belleson, president and CEO of the National Eczema Association, said in the news release. "Patients living with moderate-to-severe atopic dermatitis seek treatments that can offer durable disease control and fewer injections. This new option can ease the burden, allowing patients to spend less time thinking about managing their condition on a daily basis."