FDA Approves New Treatment for Persistent Eczema

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Sept. 17, 2024 – The FDA has approved a new treatment for persistent eczema called Ebglyss that eventually only needs to be taken once per month, offering a less frequent maintenance dose schedule than alternatives.

Ebglyss is approved for people age 12 and older with moderate to severe atopic dermatitis, which is the most common type of eczema. Ebglyss may be used when symptoms like dull to bright redness and rough skin patches, possibly with oozing and crusting, remain even after treatment with topical options like creams and ointments, according to the FDA.

The medicine is a monoclonal antibody given by injection using a prefilled pen every 2 weeks at first but may be taken just once per month as a maintenance dose. Alternative treatments typically involve daily pills or twice-monthly injections.

“Patients still struggle to control their moderate-to-severe atopic dermatitis with currently available therapies. Many experience poor long-term disease control, and severe itch can significantly impact their daily lives," said Jonathan Silverberg, MD, PhD, MPH, associate professor of dermatology at George Washington University School of Medicine and Health Sciences, in a statement from drugmaker Eli Lilly.

Silverberg worked on two studies of the medicine.

In clinical trials, 38% of people who took Ebglyss (generic name: lebrikizumab-lbkz) had clear or almost clear skin after 4 months, compared to 12% of people who took a placebo and reported similar results, according to a summary from Eli Lilly. Itch relief was among the top outcomes. 

For people who got results from the treatment, 77% maintained clear or almost clear skin after switching to once-per-month treatments for the remainder of the year. Study results also showed that some people could stop taking Ebglyss after 4 months and maintain results at the 1-year mark.

The treatment was approved for use in Europe last year and for use in Japan earlier this year. 

Common side effects were redness, swelling and itching of the eye and eyelid, reactions at the injection site, and shingles (herpes zoster).